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 useInitial U.S. Approval: 1978
Approved
Approval ID
c2e21331-4d54-4fa7-8f0d-31fe23a981aa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2024
Manufacturers
FDA
Avenacy, Inc.
DUNS: 119060628
Products 1
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 Code83634-451
Application NumberANDA210223
Product Classification
M
Marketing Category
C73584
G
Generic Name
desmopressin acetate
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateSeptember 30, 2023
FDA Product Classification
INGREDIENTS (4)
desmopressin acetateActive
Quantity: 4 ug in 1 mL
Code: XB13HYU18U
Classification: ACTIB
sodium chlorideInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
chlorobutanol hemihydrateInactive
Quantity: 5 mg in 1 mL
Code: 3X4P6271OX
Classification: IACT