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FDA Approval

Heparin Sodium

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Sagent Pharmaceuticals
DUNS: 796852890
Effective Date
October 11, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Heparin(1000 [USP'U] in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Heparin Sodium

Product Details

NDC Product Code
25021-401
Application Number
ANDA090810
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, SUBCUTANEOUS
Effective Date
August 24, 2020
HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 1000 [USP'U] in 1 mL
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
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