Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Merz Pharma GmbH & Co. KGaA
Merz North America, Inc.
342543051
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Xeomin
Product Details
NDC Product Code
46783-165Application Number
BLA125360Marketing Category
BLA (C73585)Route of Administration
INTRAMUSCULAREffective Date
September 14, 2023SucroseInactive
Code: C151H8M554Class: IACT
Botulinum toxin type AActive
Code: E211KPY694Class: ACTIBQuantity: 50 [USP'U] in 1 1
Albumin HumanInactive
Code: ZIF514RVZRClass: IACT
Xeomin
Product Details
NDC Product Code
46783-161Application Number
BLA125360Marketing Category
BLA (C73585)Route of Administration
INTRAMUSCULAREffective Date
September 14, 2023Botulinum toxin type AActive
Code: E211KPY694Class: ACTIBQuantity: 50 [USP'U] in 1 1
Albumin HumanInactive
Code: ZIF514RVZRClass: IACT
SucroseInactive
Code: C151H8M554Class: IACT
Xeomin
Product Details
NDC Product Code
46783-160Application Number
BLA125360Marketing Category
BLA (C73585)Route of Administration
INTRAMUSCULAREffective Date
September 14, 2023Botulinum toxin type AActive
Code: E211KPY694Class: ACTIBQuantity: 100 [USP'U] in 1 1
Albumin HumanInactive
Code: ZIF514RVZRClass: IACT
SucroseInactive
Code: C151H8M554Class: IACT