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
3f35d6e0-3450-4abc-a0da-cc7b277e7c6e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 2023
Manufacturers
FDA
Merz North America, Inc.
DUNS: 028147846
Products 3
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 Code46783-165
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: 50 [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 Code46783-161
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 Code46783-160
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: 100 [USP'U] in 1 1
Code: E211KPY694
Classification: ACTIB
Albumin HumanInactive
Code: ZIF514RVZR
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT