Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Shenzhen Techdow Pharmaceutical Co., Ltd.
Hepalink USA Inc.
527809171
Shenzhen Hepalink Pharmaceutical Group Co., Ltd.
Hepalink USA Inc.
547034665
Products6
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
81952-114Application Number
ANDA202733Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
September 26, 2023SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 6 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 15 mg in 1 mL
HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 5000 [USP'U] in 1 mL
Heparin Sodium
Product Details
NDC Product Code
81952-112Application Number
ANDA202957Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
September 26, 2023METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 1.5 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACTQuantity: 0.15 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 1000 [USP'U] in 1 mL
Heparin Sodium
Product Details
NDC Product Code
81952-116Application Number
ANDA203198Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
September 26, 2023METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 1.5 mg in 1 mL
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACTQuantity: 0.15 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 20000 [USP'U] in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Heparin Sodium
Product Details
NDC Product Code
81952-115Application Number
ANDA202732Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
September 26, 2023HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 1000 [USP'U] in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 9 mg in 1 mL
Heparin Sodium
Product Details
NDC Product Code
81952-111Application Number
ANDA202957Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
September 26, 2023METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 1.5 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACTQuantity: 0.15 mg in 1 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 5 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 5000 [USP'U] in 1 mL
Heparin Sodium
Product Details
NDC Product Code
81952-113Application Number
ANDA203198Marketing Category
ANDA (C73584)Route of Administration
INTRAVENOUS, SUBCUTANEOUSEffective Date
September 26, 2023SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACTQuantity: 0.15 mg in 1 mL
HeparinActive
Code: ZZ45AB24CAClass: ACTIMQuantity: 10000 [USP'U] in 1 mL
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACTQuantity: 1.5 mg in 1 mL