Desmopressin Acetate
Approved
Approval ID
23fc71d7-0367-4e71-848a-ed72957bd230
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-1129
Application NumberANDA077122
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desmopressin Acetate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2011
FDA Product Classification
INGREDIENTS (6)
DESMOPRESSIN ACETATEActive
Quantity: 0.2 mg in 1 1
Code: XB13HYU18U
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT