Home NDC 85766-155 BOTOX
Product NDC 85766-155
11-digit product format 857660155
Labeler code 85766
Product ID 85766-155_49e53ae0-1a1f-ec83-e063-6394a90a2c8d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name onabotulinumtoxinA
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRADERMAL; INTRAMUSCULAR
Labeler Sportpharm LLC
Application BLA103000
Marketing category BLA
Marketing start 1989-12-15
Substance BOTULINUM TOXIN TYPE A
Active strength 100 [USP'U]/1
Pharmacologic classes Acetylcholine Release Inhibitor [EPC], Acetylcholine Release Inhibitors [MoA], Neuromuscular Blockade [PE], Neuromuscular Blocker [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base BOTOX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BOTULINUM TOXIN TYPE A 100 [USP'U]/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination E211KPY694 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 860192 Internal RxNorm lookup 860195 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85766-155-01 BOTOX 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 1 85766-155-01 BOTOX 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 1 85766-155-02 BOTOX 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 1 85766-155-02 BOTOX 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BOTOX ONABOTULINUMTOXINA Sportpharm LLC a6f42753-d31e-4b23-8da0-4b990fee4b38 2026-02-02 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA103000 ndc (product): 85766-155 BOTOX Cosmetic ONABOTULINUMTOXINA Allergan, Inc. 485d9b71-6881-42c5-a620-a4360c7192ab 2024-10-18 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA103000 BOTOX ONABOTULINUMTOXINA Allergan, Inc. 33d066a9-34ff-4a1a-b38b-d10983df3300 2023-11-18 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA103000
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103000 Botox Cosmetic onabotulinumtoxinA 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85766-155-01 85766015501 1 VIAL in 1 CARTON (85766-155-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 1 vial 2026-02-03 No No Current 85766-155-02 85766015502 1 VIAL in 1 CARTON (85766-155-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 1 vial 2026-02-03 No No Current