Desmopressin Acetate
These highlights do not include all the information needed to use DESMOPRESSIN ACETATE INJECTION safely and effectively. See full prescribing information for DESMOPRESSIN ACETATE INJECTION. DESMOPRESSIN ACETATE injection, for intravenous or subcutaneous use Initial U.S. Approval: 1978
Approved
Approval ID
29df0492-f7ef-47bb-aa67-4ef9e5c2846f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 10, 2022
Manufacturers
FDA
Amring Pharmaceuticals Inc.
DUNS: 079843051
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Desmopressin Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69918-899
Application NumberNDA018938
Product Classification
M
Marketing Category
C73594
G
Generic Name
Desmopressin Acetate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 10, 2022
FDA Product Classification
INGREDIENTS (3)
Desmopressin AcetateActive
Quantity: 4 ug in 1 mL
Code: XB13HYU18U
Classification: ACTIB
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
Desmopressin Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69918-901
Application NumberNDA018938
Product Classification
M
Marketing Category
C73594
G
Generic Name
Desmopressin Acetate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 10, 2022
FDA Product Classification
INGREDIENTS (4)
Desmopressin AcetateActive
Quantity: 4 ug in 1 mL
Code: XB13HYU18U
Classification: ACTIB
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
ChlorobutanolInactive
Code: HM4YQM8WRC
Classification: IACT