desmopressin acetate
Desmopressin Acetate Injection, USP, 4 mcg/mL
Approved
Approval ID
2dc2cec8-6953-4a33-9356-11534fba1fb8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2020
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
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 Code62756-529
Application NumberANDA091280
Product Classification
M
Marketing Category
C73584
G
Generic Name
desmopressin acetate
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateJanuary 23, 2020
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
DESMOPRESSIN ACETATEActive
Quantity: 4 ug in 1 mL
Code: XB13HYU18U
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
CHLOROBUTANOL HEMIHYDRATEInactive
Code: 3X4P6271OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT