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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
Effective Date
June 1, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Heparin(1000 [USP'U] in 1 mL)

Products7

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
67457-384
Application Number
ANDA203851
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, SUBCUTANEOUS
Effective Date
February 11, 2019
HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 1000 [USP'U] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8.6 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 10.4 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Heparin Sodium

Product Details

NDC Product Code
67457-603
Application Number
ANDA203851
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, SUBCUTANEOUS
Effective Date
February 11, 2019
HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 10000 [USP'U] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 5 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 10.4 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT

Heparin Sodium

Product Details

NDC Product Code
67457-374
Application Number
ANDA203851
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, SUBCUTANEOUS
Effective Date
February 11, 2019
HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 5000 [USP'U] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 10.4 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Heparin Sodium

Product Details

NDC Product Code
67457-383
Application Number
ANDA203851
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, SUBCUTANEOUS
Effective Date
February 11, 2019
HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 5000 [USP'U] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 7 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 10.4 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Heparin Sodium

Product Details

NDC Product Code
67457-602
Application Number
ANDA203851
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, SUBCUTANEOUS
Effective Date
February 11, 2019
HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 10000 [USP'U] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 5 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 10.4 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT

Heparin Sodium

Product Details

NDC Product Code
67457-385
Application Number
ANDA203851
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, SUBCUTANEOUS
Effective Date
February 11, 2019
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 10.4 mg in 1 mL
HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 1000 [USP'U] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8.6 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT

Heparin Sodium

Product Details

NDC Product Code
67457-372
Application Number
ANDA203851
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS, SUBCUTANEOUS
Effective Date
February 11, 2019
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8.6 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 10.4 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 1000 [USP'U] in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
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