Home NDC 72960-112-01 DAXXIFY
Product NDC 72960-112
Requested package NDC 72960-112-01
11-digit product format 729600112
Labeler code 72960
Product ID 72960-112_71c76e28-0eb6-487e-a53b-4c9e78021e57
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name botulinum toxin type A
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR
Labeler Revance Therapeutics, Inc.
Application BLA761127
Marketing category BLA
Marketing start 2022-09-20
Substance BOTULINUM TOXIN TYPE A
Active strength 100 U/1.2mL
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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base DAXXIFY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BOTULINUM TOXIN TYPE A 100 U/1.2mL
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 2612454 Internal RxNorm lookup 2612456 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 72960-112-01 DAXXIFY 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 12 72960-112-01 DAXXIFY 1.2 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 1.2 12 72960-112-02 DAXXIFY 1.2 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 1.2 12 72960-112-02 DAXXIFY 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 12 72960-112-05 DAXXIFY 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 12 72960-112-05 DAXXIFY 1.2 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 1.2 12 72960-112-06 DAXXIFY 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 12 72960-112-06 DAXXIFY 1.2 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 1.2 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72960-112 DAXXIFY (BOTULINUM TOXIN TYPE A) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [REVANCE THERAPEUTICS, INC.] 10 Current NDC, Legacy NDC, 8 package rows 20240202_3aaa6e14-a3f7-4fb2-b9f9-d3a9c3ae1f74.zip
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 · 1 matching rows.
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761127 Daxxify daxibotulinumtoxinA-lanm 351(a) Rx 2026-09-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 72960-112-01 72960011201 1 VIAL, SINGLE-USE in 1 CARTON (72960-112-01) / 1.2 mL in 1 VIAL, SINGLE-USE 2022-09-20 0000-00-00 No No Current