FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Xeomin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BOTULINUM TOXIN TYPE A50 [USP'U]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
E211KPY694Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1009456Internal RxNorm lookup
1009459Internal RxNorm lookup
1732157Internal RxNorm lookup
1732161Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3f35d6e0-3450-4abc-a0da-cc7b277e7c6eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2a92e090-adb9-48d2-ae5f-5956e4b6ad90Product name120231024
525448fb-6d30-4c07-bb80-9a8499bd8113Product name120230627
0cf2215a-e8b6-4688-9989-d0fcd154e4b8Product name120170725
8c498f95-3b71-4acf-9882-f567b5cc4a2aProduct name120160208
e9681bd0-ddf1-421f-88c4-4337e89d5421Product name120160208
a42a1284-ee26-4b9f-a2b3-1ba05f250710Product name120151202

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46783-161-01Xeomin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,126
46783-161-01Xeomin1 in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46783-161-01EA - Each46783-161212c82bc-3c6d-4ae7-ae9a-877eef26111612025-07-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Botulinum Toxin Type AACTIVE INGREDIENTE211KPY694XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ NORTH AMERICA, INC.]7
Botulinum Toxin Type AACTIVE MOIETYE211KPY694XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ NORTH AMERICA, INC.]7
Albumin HumanINACTIVE INGREDIENTZIF514RVZRXEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ NORTH AMERICA, INC.]7
SucroseINACTIVE INGREDIENTC151H8M554XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ NORTH AMERICA, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46783-161XEOMIN (INCOBOTULINUMTOXINA) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERZ NORTH AMERICA, INC.]24Current NDC, Legacy NDC, 2 package rows20241222_3f35d6e0-3450-4abc-a0da-cc7b277e7c6e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XeominINCOBOTULINUMTOXINAMerz Pharmaceuticals, LLCccdc3aae-6e2d-4cd0-a51c-8375bfee94582026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125360
XeominINCOBOTULINUMTOXINAMerz North America, Inc.3f35d6e0-3450-4abc-a0da-cc7b277e7c6e2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125360
ndc (product): 46783-161

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125360XeominincobotulinumtoxinA351(a)Rx2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1009456incobotulinumtoxinA 100 UNT InjectionPSN3f35d6e0-3450-4abc-a0da-cc7b277e7c6e26
1009459incobotulinumtoxinA 50 UNT InjectionPSN3f35d6e0-3450-4abc-a0da-cc7b277e7c6e26
1732161XEOMIN 100 UNT InjectionPSN3f35d6e0-3450-4abc-a0da-cc7b277e7c6e26
1732157XEOMIN 50 UNT InjectionPSN3f35d6e0-3450-4abc-a0da-cc7b277e7c6e26
1732161incobotulinumtoxinA 100 UNT Injection [Xeomin]SBD3f35d6e0-3450-4abc-a0da-cc7b277e7c6e26
1732157incobotulinumtoxinA 50 UNT Injection [Xeomin]SBD3f35d6e0-3450-4abc-a0da-cc7b277e7c6e26
1009456incobotulinumtoxinA 100 UNT InjectionSCD3f35d6e0-3450-4abc-a0da-cc7b277e7c6e26
1009459incobotulinumtoxinA 50 UNT InjectionSCD3f35d6e0-3450-4abc-a0da-cc7b277e7c6e26
1732161Xeomin 100 UNT InjectionSY3f35d6e0-3450-4abc-a0da-cc7b277e7c6e26
1732157Xeomin 50 UNT InjectionSY3f35d6e0-3450-4abc-a0da-cc7b277e7c6e26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46783-161-01467830161011 VIAL, SINGLE-USE in 1 CARTON (46783-161-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE2011-08-010000-00-00NoNoCurrent