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Nabota 50U 100U 200U: Daewoong Clinic Export Toolkit

Nabota is Daewoong Pharmaceutical's prabotulinumtoxinA, supplied as 50U, 100U, and 200U vacuum-dried vials. Clinics ordering Nabota wholesale restock that three-SKU toolkit on mixed quotes from Korean B2B export. Labelled glabellar regimen is 20U across five sites; unopened vials store at 2–8°C.

Daewoong Export CartonsNabota-labelled 50U, 100U, and 200U vials from the Daewoong biologics line.
Fridge Line 2–8°CUnopened vials refrigerated; reconstituted product 24 hours at 2–8°C. Do not freeze.
Three-SKU Mix Quotes50U, 100U, and 200U procurable in one bulk order for clinic restock.
Quote-Led DispatchFedEx, EMS, air freight, or container after payment confirmation.

Nabota Wholesale: Daewoong 50U 100U 200U Clinic Toolkit

Daewoong Pharmaceutical supplies Nabota as a three-SKU clinic toolkit: 50U, 100U, and 200U vacuum-dried vials. Clinics buying Nabota wholesale restock those strengths in one mixed quote, from Korean B2B channels, packed for a 2–8°C fridge line. Direct partnership and high-volume procurement set B2B unit positioning — not a grey-market carton story.

50U covers low-waste glabellar days. 100U is the workhorse for most mixed orders. 200U is a Daewoong / MFDS strength for high-volume Korean protocols and is not an FDA SKU. We quote the carton that will actually be packed.

50U + 100U + 200U in One Mix

Most Korean type A toxin lines skip a true 50U export vial. Nabota includes it. 100U covers standard session planning. 200U reduces vial count on high-volume Korean protocols — and stays labelled as an MFDS / export strength, not a US pack.

Named Carton: Nabota, Not Sister Artwork

Jeuveau is the US 100U sister pack; Nuceiva is the EU, UK, and Canada medicine name. The carton we ship is Nabota-labelled Korean / export stock. Name the tradename on the purchase order so the fridge matches the insert.

High-Volume Korean Positioning

Unit economics come from direct Korean partnership and high-volume procurement, not from thinning the carton or substituting a sister brand. Mixed-vial quotes are priced by total vial count and export route.

2–8°C Fridge Line

Unopened vials at 2–8°C, original carton, protect from light, do not freeze. Reconstituted product 24 hours at 2–8°C. Insulated pack-out holds that line through FedEx, EMS, air freight, or container.

Nabota Cold-Chain Destinations We Currently Quote

United Arab Emirates (Dubai), Saudi Arabia, Qatar, Kuwait, Turkey, United Kingdom, Germany, Poland, France, Italy, Spain, Albania, United States, Canada, Mexico, Brazil, Colombia, Argentina, Thailand, Japan, Australia.

First-time Nabota buyers usually start with 100U, then add 50U or 200U once session maps and destination rules are clear. Restocking accounts send remaining fridge counts and the next mix; we quote from that, not from a public list price.

From Nabota Inquiry to Fridge Handoff

Nabota is quoted as a cold-chain B2B export. Strength mix, carton name, and 2–8°C pack-out are locked before anything leaves Korea.

  1. Carton and Strength Inquiry

    The buyer names Nabota 50U, 100U, 200U, or a mixed vial list, plus destination country and planned monthly volume. Sister-brand names (Jeuveau / Nuceiva) are clarified so the quoted carton matches the clinic fridge.

  2. Fridge-Line Availability Check

    We confirm 2–8°C stock, export window, and whether 200U is appropriate for that destination before the buyer locks quantity.

  3. Mixed-Vial Proforma

    A proforma is issued for the agreed Nabota strengths, vial counts, and route. This is a quote-led B2B export, not a public cart checkout.

  4. Payment Then Pack-Out

    After payment confirmation the order moves to refrigerated pack-out. Unopened vials stay in the original carton, protected from light, and are not frozen.

  5. Carrier Handoff

    Dispatch options include FedEx, EMS, air freight branch handoff, or container for distributor volume. Insulated packaging is used to keep the 2–8°C line through transit.

  6. Delivery and Next Mix

    Tracking is shared after handoff. Reorder planning uses remaining fridge inventory and the 50U / 100U / 200U mix that actually moved through clinic sessions.

Nabota Quick Product Specs

Manufacturer Daewoong Pharmaceutical Co., Ltd., Republic of Korea
Product Type 900 kDa botulinum toxin type A (prabotulinumtoxinA)
Variants Nabota 50 Units, 100 Units, 200 Units per vial
INN / USAN prabotulinumtoxinA (US: prabotulinumtoxinA-xvfs)
US Sister Pack Jeuveau 100U only — Evolus, BLA 761085, 1 February 2019 (not this carton)
EU / UK / Canada Name Nuceiva — EMA medicine 27 Sep 2019; UK PLGB 55681/0002; Canada DIN 02480158
Nabota Carton Status MFDS-registered Korean / export pack (NZ Medsafe, Singapore SIN16680P for 100U)
Technology Claim HI Pure™ / Hi-PURE — manufacturer and patent claim (US 9,512,418 B2); not a DailyMed spec
US 100U Excipients HSA 0.5 mg + NaCl 0.9 mg, no preservative (Jeuveau 100U label; do not scale to 50U/200U)
Storage Unopened 2–8°C, protect from light; do not freeze
After Reconstitution Use within 24 hours at 2–8°C; do not freeze reconstituted product
Best-Fit Buyer Clinics and distributors who need a three-SKU Nabota line and can keep cartons named correctly

Nabota 50U 100U 200U Comparison

All three Nabota strengths are vacuum-dried Daewoong vials. They are not three “FDA sizes.” Jeuveau in the United States is 100U only. Nuceiva in the EU is 50U and 100U. Nabota 200U exists on the Daewoong biologics page and the manufacturer brochure — confirm the insert in the pack before using a 200U dilution row.

VariantBest forDepth / AreaNeedleLidocaineProcurement note
Nabota 50 UnitsLow-waste glabellar sessions; EU-style 50U schedulingGlabellar map (labelled 20U across five sites)30G (EMA); 30–33G on US sister PIN/AOfficial on Daewoong biologics page and brochure. Not a US Jeuveau SKU (Jeuveau is 100U only).
Nabota 100 UnitsStandard aesthetic inventory; most mixed wholesale ordersGlabellar 20U; other uses only where the national Nabota PI lists them30–33G (US sister PI); 30G (EMA)N/AWorkhorse SKU for Nabota wholesale. Distinct carton from Jeuveau 100U NDC 72301-595-10.
Nabota 200 UnitsHigh-volume Korean protocols; fewer vials per clinic dayKR-labelled maps only when the pack insert includes them — not a US indication setConfirm against the Nabota 200U insertN/ADaewoong / MFDS SKU only. Not an FDA SKU. Not on EMA Nuceiva (50U and 100U only).
Nabota 50 Units wholesale carton

Nabota 50 Units

Specs: 50U vacuum-dried powder · Daewoong Nabota carton · 1.25 mL NaCl → 4U/0.1 mL (EMA Nuceiva 50U row / Daewoong table)

Nabota 50 Units is the small Daewoong export vial. It matches the EU Nuceiva 50U strength on paper, but the carton name, MA number, and artwork are not interchangeable. Reconstitute with 1.25 mL preservative-free 0.9% NaCl when the pack insert uses the 4U/0.1 mL glabellar concentration. Single-dose: one patient, one session; discard remainder. Not listed on US DailyMed.

Clinic Workhorse Nabota 100 Units wholesale carton

Nabota 100 Units

Specs: 100U vacuum-dried powder · 2.5 mL PF 0.9% NaCl → 4U/0.1 mL · glabellar 20U in 0.5 mL

Nabota 100 Units is the global workhorse vial and the strength that also exists as Jeuveau in the United States and as Nuceiva in the EU, UK, and Canada. The Nabota-labelled carton remains an MFDS / export pack. Labelled glabellar dilution is 2.5 mL preservative-free 0.9% NaCl → 4 Units per 0.1 mL, then 4U × 5 sites = 20U. Units are not interchangeable with other Botox brands.

MFDS / Export 200U Nabota 200 Units wholesale carton

Nabota 200 Units

Specs: 200U vacuum-dried powder · manufacturer table 5.0 mL → 4U/0.1 mL · confirm against pack insert

Nabota 200 Units is a Daewoong manufacturer SKU launched in 2015. It does not appear on the US Jeuveau label or the EMA Nuceiva SmPC. Use the manufacturer dilution table only when the vial in hand is Nabota 200U and the local insert agrees (5.0 mL → 4U/0.1 mL for the glabellar concentration). Do not treat 200U as a US-approved pack.

Nabota Manufacturer Evidence

The Daewoong brochure is manufacturer material (2018 carton strip, dilution table, process claims). Use it to identify SKUs and brochure dilution rows. Do not treat Hi-PURE chromatograms or extra-label stability plots as a licence to store outside 2–8°C or to call a Nabota vial FDA-approved.

Manufacturer Brochure

Daewoong Nabota Product Brochure

Daewoong-branded Nabota brochure covering 50U, 100U, and 200U cartons, dilution rows, and manufacturer process claims. Treat Hi-PURE figures as manufacturer/patent language, not a DailyMed specification.

Open Nabota Brochure PDF

What is Nabota?

Nabota is Daewoong Pharmaceutical’s 900 kDa prabotulinumtoxinA, produced by fermentation of Clostridium botulinum and finished as a sterile vacuum-dried powder for intramuscular injection after reconstitution. The US nonproprietary name on the Jeuveau label is prabotulinumtoxinA-xvfs. The same manufacturer family is sold under three tradenames — three labelled packs, not one interchangeable carton.

Named packs of the Daewoong prabotulinumtoxinA family
Carton Who markets it Official strengths What that carton is
Nabota Daewoong Pharmaceutical Co., Ltd. 50U, 100U, 200U Korean / export carton. MFDS listing “NABOTA inj.” — approved in Korea in 2013, launched 2014. NZ Medsafe and Singapore SIN16680P list Nabota 100U.
Jeuveau Evolus, Inc. (US License 2070) 100U only (NDC 72301-595-10) US sister pack. BLA 761085, FDA approved 1 February 2019, marketed from 13 February 2019. Glabellar lines in adults only.
Nuceiva Evolus Pharma B.V. (EU MAH); Evolus in Canada / UK listings EU 50U and 100U; Canada 100U Medicine — not a CE device. EMA MA 27 September 2019 (EU/1/19/1364). UK PLGB 55681/0002. Canada DIN 02480158, NOC 16 August 2018.

MFDS English biological-products listing (seq=70651) names the brand “NABOTA inj.”, active “Clostridium Botulinum Toxin Type A,” and the glabellar indication on that page. “Korean FDA” wording on that English page is historical; the agency is the Ministry of Food and Drug Safety. A Nabota-labelled vial is an MFDS / export pack, not the FDA product.

US label (DailyMed, April 2023): prabotulinumtoxinA-xvfs is a 900 kDa botulinum toxin type A. Class: acetylcholine release inhibitor and neuromuscular blocking agent. ATC M03AX01. Manufacturing site on the US BLA: Daewoong, Hwaseong-si, Gyeonggi-Do. Same manufacturer and INN family; different tradename, carton, NDC/MA number, and labelled indication set.

Nabota SKU map showing 50U 100U 200U vials and labelled-use differences by market
Nabota manufacturer SKU and indication map — 50U, 100U, and 200U export vials versus sister-brand packs. KR-only uses are not US Jeuveau indications.

How Nabota Works & Composition

The US Jeuveau PI describes binding to motor-nerve terminals, internalisation, cleavage of SNAP-25, inhibition of acetylcholine release, and partial chemical denervation of the injected muscle. That mechanism language belongs to the 900 kDa type A complex. Units still cannot be converted across Botox brands.

Acetylcholine Release Inhibitor

  1. Binding: The 900 kDa complex binds at cholinergic motor-nerve terminals.
  2. Internalisation: The bound complex is taken into the nerve terminal.
  3. SNAP-25 cleavage: The light chain cleaves SNAP-25, blocking acetylcholine vesicle release.
  4. Clinical effect: Partial chemical denervation of the injected muscle until sprouting restores transmission.

Labelled onset: NZ Nabota data sheet — typically chemical denervation two days after injection, increasing during the first two weeks. EMA Nuceiva SmPC — clinical signs within 2–3 days, peak within 4 weeks, recovery normally within 12 weeks. Singapore NDF glabellar — typically one to two days, increasing during the first week; each treatment lasts approximately three to four months. US PI primary efficacy endpoint is Day 30; Highlights do not publish a numeric onset-day. A Korean open-label Phase IV onset paper (Song et al.) is not the US PI.

US retreatment: no more frequently than every three months. Cumulative dose must be considered if other botulinum toxin products are also used.

DailyMed Jeuveau 100U — Do Not Scale Milligrams

Composition milligrams below are the US 100U Jeuveau vial. EMA Nuceiva lists the same two excipients for 50U and 100U but does not publish milligram amounts in the retrieved SmPC. Do not invent HSA or NaCl quantities for Nabota 50U or 200U.

Component Amount per 100U vial Note
Botulinum toxin type A neurotoxin complex 100 Units One Unit = mouse i.p. LD50 relative to Evolus’ reference standard
Human serum albumin (HSA) 0.5 mg US 100U label only
Sodium chloride 0.9 mg US 100U label only
Preservative None Single-dose vial; discard remainder
Presentation Sterile vacuum-dried powder Beer 2019: US Phase III used vacuum-dried commercial formulation, not the earlier Korean freeze-dried comparator

DailyMed: units of biological activity of Jeuveau cannot be converted into units of any other botulinum toxin. That rule applies to clinic planning even when the carton in the fridge says Nabota.

HI Pure™ — Manufacturer and Patent Language

Daewoong’s English biologics page lists “HI Pure™ Technology (KR patent No.13-39349, US Patent No. 9,512,418)” under Nabota. The 2018 brochure cites Korean Patent registration KR 10-1339349 (2013) and a size-exclusion chromatogram of a single 900 kDa peak. US 9,512,418 B2 (issued 6 December 2016, assignee Daewoong) describes acid precipitation plus anion-exchange chromatography and, in the specification, HPLC purity after chromatography of 98.38% (primary) and 98.99% (secondary), with a claim of botulinum type A protein “having a purity of at least 98%.”

Those figures are manufacturer and patent claims. No independent lot assay of commercial Nabota or Jeuveau vials was used as a label spec for this page. DailyMed does not state a purity percentage. Do not present 98%, 98.7%, or 98.38% as an FDA specification.

Labelled Uses by Market

Glabellar 20U (4U × 5 intramuscular sites) is the common labelled aesthetic regimen across Jeuveau, Nuceiva, NZ Nabota, and Daewoong / MFDS-facing PI. Additional Korean indications are not US Jeuveau indications. The Jeuveau boxed warning states Jeuveau is not approved for spasticity or any condition other than glabellar lines.

Glabellar Map (Labelled 20U)

  • Total 20 Units = 4 Units (0.1 mL) × 5 sites
  • Inferomedial corrugator, right
  • Superior middle corrugator, right
  • Mid-line procerus
  • Inferomedial corrugator, left
  • Superior middle corrugator, left
  • Lateral corrugator injections at least 1 cm above the bony supraorbital ridge
  • Do not inject closer than 1 cm above the central eyebrow

KR-Labelled Uses — Not US / FDA

  • Lateral canthal lines (crow's feet): Singapore NDF 4U/0.1 mL × 3 sites per side = 24U both sides — not a US Jeuveau indication
  • Benign essential blepharospasm: NDF initial 2.5U per listed pretarsal sites, up to 5U/site, total up to 50U — not US
  • Focal upper-limb spasticity after stroke: NDF notes study doses ranging up to 360 units — KR indication; Jeuveau boxed warning forbids presenting this as a US approved use
  • Benign masseteric hypertrophy: NDF 8U (0.2 mL) × 3 sites per side = 48U; MFDS approval announced 25 August 2023 — not on the live English Daewoong biologics page at dossier retrieval, not FDA

Daewoong English biologics page (retrieved 30 August 2026) lists glabellar (KR, US, EU, Canada — US/EU/Canada are Jeuveau/Nuceiva names), upper limb spasticity (KR), lateral canthal lines (KR), and blepharospasm associated with dystonia (KR). EMA Nuceiva indication is narrower still: temporary improvement of moderate to severe vertical glabellar lines at maximum frown when the severity has an important psychological impact, in adults below 65 years of age. EMA: not recommended over 65 years. US trials included 68 subjects ≥65; not sufficient to determine a different response. Pediatric use: safety and effectiveness not established (US); EMA: no relevant paediatric use.

US Pivotal Data & Head-to-Head

US product-page efficacy for glabella must follow DailyMed Table 3. Beer 2019 publishes the same trials to one decimal place; they round, they do not contradict. EVB-003 (Rzany 2020) is a Europe/Canada head-to-head on a different endpoint. None of these datasets make a Nabota-labelled vial FDA-approved.

EV-001 and EV-002 — DailyMed Copy-Safe

Two identical US randomised, multicenter, double-blind, placebo-controlled, single-dose trials. Dose 20U (4U × 5 sites). Primary endpoint: Day 30 composite, investigator and subject independently agree ≥2-grade improvement on 4-point GLS at maximum frown.

Composite investigator + subject ≥2-grade GLS improvement at maximum frown, Day 30 (DailyMed Table 3)
Trial ClinicalTrials.gov Jeuveau Placebo
EV-001 NCT02334423 N=246 · 68% N=84 · 1%
EV-002 NCT02334436 N=246 · 70% N=78 · 1%

Combined DailyMed randomised: 654 (Jeuveau 492 / placebo 162). Beer 2019 ITT: 67.5% vs 1.2% (EV-001) and 70.4% vs 1.3% (EV-002); both p<0.001. No SAE in either study was assessed as study-drug related. Demographics (DailyMed): mean age 51 years; 68 subjects (10%) ≥65; 91% women; 84% White; age range 18–81.

Adverse Reactions — DailyMed Table 2

AEs at higher frequency (≥1%) in Jeuveau vs placebo, EV-001 + EV-002
Event Jeuveau N=492 Placebo N=162
Headache 57 (12%) 21 (13%)
Eyelid ptosis 8 (2%) 0 (0%)
Upper respiratory tract infection 13 (3%) 1 (1%)
White blood cell count increase 6 (1%) 0 (0%)

Open-label repeat-dose EV-004 (NCT02184988) and EV-006 (NCT02428608): n=922; 20U up to a maximum total of 80U; median 3 treatments; AE profile similar to single-dose trials (DailyMed). Immunogenicity (DailyMed §6.2): among 1,414 subjects treated with prabotulinumtoxinA-xvfs, 2 pre-existing antibodies and 2 treatment-emergent antibodies. Assay comparison across products may be misleading (label caveat).

EVB-003 — Different Endpoint, Do Not Substitute

Rzany BJ et al., Aesthetic Surgery Journal 2020;40(4):413–429, PMID 30951166. Europe/Canada Phase III vs onabotulinumtoxinA, 150-day, double-blind, 5:5:1 randomisation, n=540 (prabo 20U n=245; ona 20U n=246; placebo n=49). Primary: investigator GLS 0 or 1 at maximum frown on Day 30. Responder rates: prabo 87.2%; ona 82.8%; placebo 4.2%. Absolute difference 4.4% (95% CI −1.9, 10.8); lower bound greater than −10.0% → non-inferiority. SAE in 5 patients; none study-drug related. EMA SmPC Table 2 reports the same Day 30 investigator GLS 0/1 rates on the PP population. This supports non-inferiority to 20U onabotulinumtoxinA on that endpoint. It does not support unit interchangeability, superiority as a label claim, or “same as Botox” marketing. A 2022 male post-hoc (PMID 35922149) did not reach statistical significance between arms.

Won 2015 and Nam 2015 — Korean Programmes

Won CH et al., Int J Dermatol 2015;54(2):227–234, PMID 25311357. DWP450 vs onabotulinumtoxinA, n=268 randomised 1:1, 20U each. Physician-rating responder rates at week 4 (maximal contraction): DWP450 93.89%; OBoNT 88.64%. Non-inferiority: lower limit of 97.5% one-sided CI −1.53%, above the −15% threshold. Beer 2019 states this Korean comparator used the original formulation; the US/EU commercial product is vacuum-dried with a specified HSA source. Quote Won 2015 as the original-formulation Korean H2H, not as the Jeuveau BLA primary analysis.

Nam HS et al., J Neurol Sci 2015;357(1–2):192–197, PMID 26233808. Post-stroke upper-limb spasticity, n=197 (Nabota 99 / Botox 98). Wrist-flexor MAS change to week 4: −1.44 ± 0.72 vs −1.46 ± 0.77; difference 0.0129 (95% CI −0.2062 to 0.2319), within non-inferiority margin 0.45. This supported MFDS approval for post-stroke ULS (secondary sources cite MFDS 7 December 2015). It is not a US Jeuveau indication.

Nabota Carton Checks

These are visual and handling checks a receiving clinic can run on the Nabota carton. They are not a Yaksu document or batch-file promise.

Read the Tradename on the Carton

Nabota, Jeuveau, and Nuceiva are different labelled packs of the same Daewoong active. A Nabota vial is not a US-approved carton. Reject stock if the outer name does not match the Nabota order.

Lot and Expiry on Carton and Vial

Match lot number and expiry between the outer carton and the vial label. Any mismatch is a rejection trigger before reconstitution.

Vacuum Pull on Diluent

US, EU, and NZ instructions: slowly inject preservative-free 0.9% NaCl. Discard the vial if a vacuum does not pull the diluent in. Gently rotate; do not foam.

Strength Colour and Seal

Daewoong brochure colour code: 50U purple, 100U green, 200U orange. Confirm factory seal, print quality, and unit strength against the purchase order before the vial enters the fridge line.

Storage, Dilution & Safety

Local pack always prevails. The tables below are label-specific. Do not mix US 36-month dating with EMA 30-month dating, and do not treat manufacturer extra-label stability plots as a licence to leave reconstituted toxin at room temperature or in a freezer.

Unopened storage and reconstituted dating (do not mix columns)
Parameter US Jeuveau (DailyMed Apr 2023; FDA letter 1 Feb 2019) EU Nuceiva (EMA SmPC) NZ Nabota 100U (Medsafe)
Unopened Refrigerator 2–8°C, original carton, protect from light. Do not freeze Refrigerator 2–8°C Refrigerator 2–8°C. Do not freeze
Unopened dating 36 months from date of manufacture (final sterile filtration of formulated DP) at 2–8°C 30 months (50U and 100U) 36 months
After reconstitution Use within 24 h; fridge 2–8°C, original carton, protect from light. Do not freeze reconstituted product Chemical/physical in-use stability 72 h at 2–8°C; microbiological default use immediately, normally not longer than 24 h at 2–8°C unless reconstitution was aseptic and validated Fridge 2–8°C up to 24 hours. Do not freeze
Appearance after reconstitution Clear, colourless, free of particulate matter, or do not inject Same Same

Reconstitution — 100U US PI (Copy-Safe)

Diluent: sterile, preservative-free 0.9% Sodium Chloride Injection, USP only. Slowly inject into the vacuum-dried vial. Discard the vial if a vacuum does not pull the diluent in. Gently rotate; do not foam. Single-dose; one patient, one session; discard remainder. No preservative.

DailyMed Jeuveau 100U — the only US-label dilution
Diluent added to 100 Unit vial Resulting dose per 0.1 mL
2.5 mL 4 Units

Total glabellar treatment dose at this dilution: 20 Units in 0.5 mL. Draw at least 0.5 mL; expel air; 30–33 gauge needle (US PI).

EMA Nuceiva 50U and 100U — Same 4U/0.1 mL Target

Vial Amount of NaCl 9 mg/mL (0.9%) Resulting dose per 0.1 mL
50 Units 1.25 mL 4 Units
100 Units 2.5 mL 4 Units

Needle: sterile 30 gauge (EMA).

Manufacturer Brochure Dilution Table — Includes 200U

Not a US PI table. Use only when the pack is a Nabota 50/100/200U vial and the local PI agrees. Cited in the Daewoong brochure to “Nabota product information.”

Diluent for 50U Diluent for 100U Diluent for 200U Resulting dose (U / 0.1 mL)
0.5 mL 1.0 mL 2.0 mL 10.0 U
1.0 mL 2.0 mL 4.0 mL 5.0 U
1.25 mL 2.5 mL 5.0 mL 4.0 U
2.0 mL 4.0 mL 8.0 mL 2.5 U
4.0 mL 8.0 mL 16.0 mL 1.25 U

The 4.0 U / 0.1 mL row is the glabellar labelled concentration in US, EU, NZ, and Singapore NDF (100U / 2.5 mL). Do not invent other clinic-custom dilutions as labelled.

Contraindications

  • US Jeuveau: known hypersensitivity to any botulinum toxin preparation or to any component; infection at the proposed injection site(s)
  • EMA Nuceiva additionally: generalised disorders of muscle activity (e.g. myasthenia gravis or Eaton Lambert syndrome); infection or inflammation at sites
  • Singapore NDF / NZ-style Nabota PI additionally list neuromuscular junctional disorders (MG, LEMS, ALS) and, in NDF wording, pregnant women / women of childbearing potential or nursing mothers
  • US PI does not contraindicate pregnancy the same way: data insufficient; rat embryo-fetal study up to 4 U/kg without treatment-related fetal effects (DailyMed §8.1). EMA: not recommended in pregnancy or in women of childbearing potential not using contraception; should not be used during breast-feeding

Boxed Warning and Class Cautions

  • Distant spread of toxin effect: symptoms consistent with botulinum toxin effects reported hours to weeks after injection; swallowing and breathing difficulties can be life threatening; reports of death
  • Jeuveau is not approved for the treatment of spasticity or any conditions other than glabellar lines
  • Units not interchangeable; serious AEs with unapproved use; hypersensitivity (anaphylaxis, serum sickness, urticaria, soft-tissue edema, dyspnea)
  • Cardiovascular events including arrhythmia and MI (some fatal) after botulinum toxins — caution in pre-existing CVD
  • Pre-existing neuromuscular disorders may amplify typical doses; dysphagia / breathing difficulty; ophthalmic AEs including dry eye
  • HSA theoretical remote viral/CJD risk (no identified cases for licensed albumin)
  • Drug interactions (DailyMed §7, no formal DDI studies): aminoglycosides or other agents interfering with neuromuscular transmission; anticholinergic drugs; other botulinum neurotoxin products; muscle relaxants — observe closely
Nabota certification and safety overview for Daewoong prabotulinumtoxinA export vials
Nabota certification and safety overview. Jeuveau holds the US BLA; Nabota-labelled vials remain MFDS / export packs. Nuceiva is an EMA medicine, not a CE mark.

Visible Improvements (Before & After)

Glabellar 20U is the labelled aesthetic regimen most clinics plan against when they order Nabota 100U. The frames below are before and after visual examples of frown-line treatment — not labelled as real clinical trial photographs.

Nabota glabellar frown lines before and after visual example
Nabota glabellar frown lines — before and after visual example for 20U five-site protocol planning.
Nabota glabellar frown before and after visual example, second angle
Second Nabota glabellar before and after visual example — corrugator and procerus frown at rest versus after mapped 20U.

Nabota Wholesale FAQ

Wholesale & MOQ

How do clinics request Nabota wholesale pricing?

Send a WhatsApp inquiry with the Nabota strengths you need (50U, 100U, 200U, or mixed), destination country, and estimated monthly vial count. Quotes are built from volume and export route — this is not a public checkout price.

Can 50U, 100U, and 200U ship in one Nabota bulk order?

Yes. Mixed-strength Nabota orders are standard. 200U is a Daewoong / MFDS SKU and is not an FDA SKU, so destination fit is confirmed before the proforma is locked.

Shipping & Storage

What fridge conditions apply to Nabota export?

Unopened Nabota vials are stored at 2–8°C in the original carton, protected from light, and must not be frozen. After reconstitution, US/NZ/Daewoong PI language is use within 24 hours at 2–8°C; do not freeze reconstituted product. Extra-label room-temperature or freezer plots from manufacturer data-on-file are not a licence to store outside the insert.

How long does an unopened vial last?

Dating is label-specific. The US Jeuveau letter uses 36 months at 2–8°C. EMA Nuceiva lists 30 months for 50U and 100U. The NZ Nabota 100U data sheet lists 36 months. Always follow the dating printed on the carton in hand.

Authenticity

Is Nabota FDA approved?

No. A Nabota-labelled 50U, 100U, or 200U vial is an MFDS / export pack, not a US-approved carton. Jeuveau (prabotulinumtoxinA-xvfs) is the US sister pack: Evolus, BLA 761085, approved 1 February 2019, 100U vial NDC 72301-595-10, glabellar lines in adults only. Same manufacturer family; different tradename, carton, and labelled indication set.

Is Nuceiva CE marked?

No. Nuceiva is a medicine. It received an EU centralised marketing authorisation on 27 September 2019 (EU/1/19/1364). The UK listing is MHRA GB MA PLGB 55681/0002. Canada is DIN 02480158 (NOC 16 August 2018). Do not describe Nuceiva or Nabota as a CE-marked device.

Variants

Which Nabota vial should a clinic stock first?

Nabota 100 Units is the usual first line because it matches the labelled 2.5 mL → 4U/0.1 mL glabellar map used across Jeuveau, Nuceiva, NZ Nabota, and Daewoong-facing PI. Add 50U when session waste on 20U glabellar maps matters. Add 200U only when the local Nabota insert supports it — it is not a US FDA SKU.

Are Nabota units interchangeable with Botox?

No. Every retrieved PI states that units of biological activity cannot be converted into units of any other botulinum toxin product. Reseller “1:1 with Botox” is not a label statement. Head-to-head trials (Won 2015; Rzany 2020 / EVB-003) concluded non-inferiority on their own endpoints — that is not interchangeability.

Clinical Overview

What US efficacy numbers should buyers quote for glabella?

DailyMed Table 3 (Jeuveau, Day 30, composite investigator + subject ≥2-grade GLS improvement at maximum frown): EV-001 68% (n=246) vs placebo 1% (n=84); EV-002 70% (n=246) vs 1% (n=78). Total randomised 654. Do not replace those figures with EVB-003’s 87.2% / 82.8% investigator GLS 0-or-1 rates — that is a different endpoint in a Europe/Canada trial.

What adverse reactions appear in the US pivotal pool?

DailyMed Table 2, EV-001 + EV-002: Jeuveau n=492 vs placebo n=162. Headache 12% vs 13%; eyelid ptosis 2% vs 0%; upper respiratory tract infection 3% vs 1%; white blood cell count increase 1% vs 0%.

Is Hi-PURE 98% a DailyMed specification?

No. HI Pure™ / Hi-PURE and “at least 98%” 900 kDa language are manufacturer and patent claims (KR 10-1339349; US 9,512,418 B2). DailyMed does not state a purity percentage. Do not present 98%, 98.7%, or 98.38% as an FDA specification.