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Desmopressin Acetate

Desmporessin Acetate Tablets 0.1 mg, 0.2 mg

Approved
Approval ID

c7253d3d-13a7-49f3-876d-8c07dbbe7ff3

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 17, 2023

Manufacturers
FDA

REMEDYREPACK INC.

DUNS: 829572556

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 Code70518-3148
Application NumberANDA077414
Product Classification
M
Marketing Category
C73584
G
Generic Name
desmopressin acetate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 17, 2023
FDA Product Classification

INGREDIENTS (4)

STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DESMOPRESSIN ACETATEActive
Quantity: 0.1 mg in 1 1
Code: XB13HYU18U
Classification: ACTIB

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Desmopressin Acetate - FDA Drug Approval Details