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Xeomin

These highlights do not include all the information needed to use XEOMIN safely and effectively. See full prescribing information for XEOMIN. XEOMIN (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use Initial U.S. Approval: 2010

Approved
Approval ID

ccdc3aae-6e2d-4cd0-a51c-8375bfee9458

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 14, 2023

Manufacturers
FDA

Merz Pharmaceuticals, LLC

DUNS: 126209282

Products 5

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

incobotulinumtoxinA

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0259-1610
Application NumberBLA125360
Product Classification
M
Marketing Category
C73585
G
Generic Name
incobotulinumtoxinA
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 14, 2023
FDA Product Classification

INGREDIENTS (3)

Albumin HumanInactive
Code: ZIF514RVZR
Classification: IACT
Botulinum Toxin Type AActive
Quantity: 100 [USP'U] in 1 1
Code: E211KPY694
Classification: ACTIB
SucroseInactive
Code: C151H8M554
Classification: IACT

incobotulinumtoxinA

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0259-1605
Application NumberBLA125360
Product Classification
M
Marketing Category
C73585
G
Generic Name
incobotulinumtoxinA
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 14, 2023
FDA Product Classification

INGREDIENTS (3)

Botulinum Toxin Type AActive
Quantity: 50 [USP'U] in 1 1
Code: E211KPY694
Classification: ACTIB
Albumin HumanInactive
Code: ZIF514RVZR
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT

incobotulinumtoxinA

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0259-1620
Application NumberBLA125360
Product Classification
M
Marketing Category
C73585
G
Generic Name
incobotulinumtoxinA
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 14, 2023
FDA Product Classification

INGREDIENTS (3)

Albumin HumanInactive
Code: ZIF514RVZR
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT
Botulinum Toxin Type AActive
Quantity: 200 [USP'U] in 1 1
Code: E211KPY694
Classification: ACTIB

incobotulinumtoxinA

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0259-4110
Application NumberBLA125360
Product Classification
M
Marketing Category
C73585
G
Generic Name
incobotulinumtoxinA
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 14, 2023
FDA Product Classification

INGREDIENTS (3)

SucroseInactive
Code: C151H8M554
Classification: IACT
Botulinum Toxin Type AActive
Quantity: 100 [USP'U] in 1 1
Code: E211KPY694
Classification: ACTIB
Albumin HumanInactive
Code: ZIF514RVZR
Classification: IACT

incobotulinumtoxinA

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0259-4150
Application NumberBLA125360
Product Classification
M
Marketing Category
C73585
G
Generic Name
incobotulinumtoxinA
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 14, 2023
FDA Product Classification

INGREDIENTS (3)

Botulinum Toxin Type AActive
Quantity: 50 [USP'U] in 1 1
Code: E211KPY694
Classification: ACTIB
SucroseInactive
Code: C151H8M554
Classification: IACT
Albumin HumanInactive
Code: ZIF514RVZR
Classification: IACT

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Xeomin - FDA Drug Approval Details