botox cosmetic

Generic: onabotulinumtoxina

Labeler: allergan, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name botox cosmetic
Generic Name onabotulinumtoxina
Labeler allergan, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

botulinum toxin type a 50 [USP'U]/1

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 0023-3919
Product ID 0023-3919_265710db-c7b9-42ff-9fc8-c24a936c1d87
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA103000
Listing Expiration 2027-12-31
Marketing Start 2008-07-15

Pharmacologic Class

Established (EPC)
acetylcholine release inhibitor [epc] neuromuscular blocker [epc]
Mechanism of Action
acetylcholine release inhibitors [moa]
Physiologic Effect
neuromuscular blockade [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00233919
Hyphenated Format 0023-3919

Supplemental Identifiers

RxCUI
860192 1726293 1726296 1726313
UPC
0300239232013
UNII
E211KPY694
NUI
N0000175771 N0000193962 N0000175731 N0000175770

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name botox cosmetic (source: ndc)
Generic Name onabotulinumtoxina (source: ndc)
Application Number BLA103000 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 50 [USP'U]/1
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (0023-3919-50) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
  • 1 VIAL, GLASS in 1 CARTON (0023-3919-51) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS
source: ndc

Packages (2)

0023-3919-50 1 VIAL, GLASS in 1 CARTON (0023-3919-50) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS 0023-3919-51 1 VIAL, GLASS in 1 CARTON (0023-3919-51) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS

Ingredients (1)

botulinum toxin type a (50 [USP'U]/1)

Linked Drug Pages (1)

BOTOX Cosmetic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "265710db-c7b9-42ff-9fc8-c24a936c1d87", "openfda": {"nui": ["N0000175771", "N0000193962", "N0000175731", "N0000175770"], "upc": ["0300239232013"], "unii": ["E211KPY694"], "rxcui": ["860192", "1726293", "1726296", "1726313"], "spl_set_id": ["485d9b71-6881-42c5-a620-a4360c7192ab"], "pharm_class_pe": ["Neuromuscular Blockade [PE]"], "pharm_class_epc": ["Acetylcholine Release Inhibitor [EPC]", "Neuromuscular Blocker [EPC]"], "pharm_class_moa": ["Acetylcholine Release Inhibitors [MoA]"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (0023-3919-50)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS", "package_ndc": "0023-3919-50", "marketing_start_date": "20080715"}, {"sample": true, "description": "1 VIAL, GLASS in 1 CARTON (0023-3919-51)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS", "package_ndc": "0023-3919-51", "marketing_start_date": "20080715"}], "brand_name": "BOTOX Cosmetic", "product_id": "0023-3919_265710db-c7b9-42ff-9fc8-c24a936c1d87", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Acetylcholine Release Inhibitor [EPC]", "Acetylcholine Release Inhibitors [MoA]", "Neuromuscular Blockade [PE]", "Neuromuscular Blocker [EPC]"], "product_ndc": "0023-3919", "generic_name": "onabotulinumtoxinA", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BOTOX Cosmetic", "active_ingredients": [{"name": "BOTULINUM TOXIN TYPE A", "strength": "50 [USP'U]/1"}], "application_number": "BLA103000", "marketing_category": "BLA", "marketing_start_date": "20080715", "listing_expiration_date": "20271231"}