DESMOPRESSIN ACETATE
These highlights do not include all the information needed to use DESMOPRESSIN ACETATE INJECTION USP safely and effectively. See full prescribing information for DESMOPRESSIN ACETATE INJECTION USP. DESMOPRESSIN ACETATE injection, for intravenous or subcutaneous use Initial U.S. Approval: 1978
Approved
Approval ID
b2fad59d-6176-4e09-9fbb-5cdd7f8f1568
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 16, 2023
Manufacturers
FDA
UBI Pharma Inc.
DUNS: 658871159
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 Code72843-459
Application NumberANDA210218
Product Classification
M
Marketing Category
C73584
G
Generic Name
DESMOPRESSIN ACETATE
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRAVENOUS
Effective DateOctober 16, 2023
FDA Product Classification
INGREDIENTS (1)
DESMOPRESSIN ACETATEActive
Quantity: 4 ug in 1 mL
Code: XB13HYU18U
Classification: ACTIB