Home NDC 46783-161 Xeomin
Product NDC 46783-161
11-digit product format 467830161
Labeler code 46783
Product ID 46783-161_cc302fc7-e87f-41ff-b716-388abdbf957a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name incobotulinumtoxinA
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR
Labeler Merz North America, Inc.
Application BLA125360
Marketing category BLA
Marketing start 2011-08-01
Substance BOTULINUM TOXIN TYPE A
Active strength 50 [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 openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Xeomin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BOTULINUM TOXIN TYPE A 50 [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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1009456 Internal RxNorm lookup 1009459 Internal RxNorm lookup 1732157 Internal RxNorm lookup 1732161 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 46783-161-01 Xeomin 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 26 46783-161-01 Xeomin 1 in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 1 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Botulinum Toxin Type A ACTIVE INGREDIENT E211KPY694 XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ NORTH AMERICA, INC.] 7 Botulinum Toxin Type A ACTIVE MOIETY E211KPY694 XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ NORTH AMERICA, INC.] 7 Albumin Human INACTIVE INGREDIENT ZIF514RVZR XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ NORTH AMERICA, INC.] 7 Sucrose INACTIVE INGREDIENT C151H8M554 XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ NORTH AMERICA, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46783-161 XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ NORTH AMERICA, INC.] 24 Current NDC, Legacy NDC, 2 package rows 20241222_3f35d6e0-3450-4abc-a0da-cc7b277e7c6e.zip
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125360 Xeomin incobotulinumtoxinA 351(a) Rx 2026-06-01
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 46783-161-01 46783016101 1 VIAL, SINGLE-USE in 1 CARTON (46783-161-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE 2011-08-01 0000-00-00 No No Current