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Desmopressin Acetate

These highlights do not include all the information needed to use DESMOPRESSIN ACETATE INJECTION safely and effectively. See full prescribing information for DESMOPRESSIN ACETATE INJECTION. DESMOPRESSIN ACETATE injection, for intravenous or subcutaneous use Initial U.S. Approval: 1978

Approved
Approval ID

131fd4d8-48ca-4c1f-8165-848dc0a4d511

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 10, 2022

Manufacturers
FDA

Amring Pharmaceuticals Inc.

DUNS: 079843051

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 Code69918-901
Application NumberNDA018938
Product Classification
M
Marketing Category
C73594
G
Generic Name
Desmopressin Acetate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 10, 2022
FDA Product Classification

INGREDIENTS (4)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
DESMOPRESSIN ACETATEActive
Quantity: 4 ug in 1 mL
Code: XB13HYU18U
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
CHLOROBUTANOLInactive
Code: HM4YQM8WRC
Classification: IACT

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Desmopressin Acetate - FDA Drug Approval Details