Desmopressin Acetate
DESMOPRESSIN ACETATE NASAL SOLUTION (NASAL SPRAY)
Approved
Approval ID
80ee3c8b-0b8f-4261-bb64-a47c4c9b96bb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
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 Code70771-1314
Application NumberANDA091345
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desmopressin Acetate
Product Specifications
Route of AdministrationNASAL
Effective DateOctober 31, 2022
FDA Product Classification
INGREDIENTS (6)
DESMOPRESSIN ACETATEActive
Quantity: 0.1 mg in 1 mL
Code: XB13HYU18U
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT