Home NDC 0259-1610 Xeomin
Product NDC 0259-1610
11-digit product format 002591610
Labeler code 0259
Product ID 0259-1610_b3e7ca89-65bb-4fce-ad79-b0d6b6a005cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name incobotulinumtoxinA
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR
Labeler Merz Pharmaceuticals, LLC
Application BLA125360
Marketing category BLA
Marketing start 2010-09-01
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 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 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000107 Internal RxNorm lookup 1009456 Internal RxNorm lookup 1009459 Internal RxNorm lookup 1732157 Internal RxNorm lookup 1732161 Internal RxNorm lookup 1732165 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 0259-1610-01 Xeomin 1 in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 1 32 0259-1610-01 Xeomin 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 32
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 PHARMACEUTICALS, LLC] 12 Botulinum Toxin Type A ACTIVE MOIETY E211KPY694 XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ PHARMACEUTICALS, LLC] 12 Albumin Human INACTIVE INGREDIENT ZIF514RVZR XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ PHARMACEUTICALS, LLC] 12 Sucrose INACTIVE INGREDIENT C151H8M554 XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ PHARMACEUTICALS, LLC] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0259-1610 XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ PHARMACEUTICALS, LLC] 30 Current NDC, Legacy NDC, 2 package rows 20241222_ccdc3aae-6e2d-4cd0-a51c-8375bfee9458.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 0259-1610-01 00259161001 1 VIAL, SINGLE-USE in 1 CARTON (0259-1610-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE 2010-09-01 0000-00-00 No No Current