MedPath

desmopressin acetate

Desmopressin Acetate Injection, USPFor Intravenous or Subcutaneous Use Only

Approved
Approval ID

40752c75-d09b-4013-9024-442048145b63

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 14, 2020

Manufacturers
FDA

Sagent Pharmaceuticals

DUNS: 796852890

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 Code25021-461
Application NumberANDA204751
Product Classification
M
Marketing Category
C73584
G
Generic Name
desmopressin acetate
Product Specifications
Route of AdministrationINTRAVENOUS, SUBCUTANEOUS
Effective DateAugust 14, 2020
FDA Product Classification

INGREDIENTS (4)

hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
chlorobutanolInactive
Code: HM4YQM8WRC
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
desmopressin acetateActive
Quantity: 40 ug in 10 mL
Code: XB13HYU18U
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

desmopressin acetate - FDA Drug Approval Details