Desmopressin Acetate
Desmopressin Acetate Tablets Rx only
Approved
Approval ID
c01048e8-d28f-4085-9c37-3d5d48395a77
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 21, 2021
Manufacturers
FDA
Amring Pharmaceuticals Inc.
DUNS: 079843051
Products 2
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 Code69918-201
Application NumberNDA019955
Product Classification
M
Marketing Category
C73594
G
Generic Name
Desmopressin Acetate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2020
FDA Product Classification
INGREDIENTS (5)
DESMOPRESSIN ACETATEActive
Quantity: 0.2 mg in 1 1
Code: XB13HYU18U
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
Desmopressin Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69918-101
Application NumberNDA019955
Product Classification
M
Marketing Category
C73594
G
Generic Name
Desmopressin Acetate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2020
FDA Product Classification
INGREDIENTS (5)
DESMOPRESSIN ACETATEActive
Quantity: 0.1 mg in 1 1
Code: XB13HYU18U
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT