Last Updated: August 9, 2026

Details for New Drug Application (NDA): 206552

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NDA 206552 describes HEPARIN SODIUM, which is a drug marketed by Abraxis Pharm, Aspen Global Inc, B Braun Medical, Be Pharms, Casi Pharms Inc, Chamberlin Parenterl, Dell Labs, Dr Reddys, Emerge Bioscience, Epic Pharma Llc, Fresenius Kabi Usa, Gland, Hikma, Hospira, Hospira Inc, Lilly, Luitpold, Parke Davis, Pfizer, Pharm Spec, Pharmacia And Upjohn, Pharmobedient, Plano Pharms, Sagent Pharms, Shenzhen Techdow, Smith And Nephew, Solopak, Watson Labs Inc, Baxter Hlthcare, Mcgaw, B Braun, and Pharma Serve Ny, and is included in sixty-nine NDAs. It is available from twenty-three suppliers. Additional details are available on the HEPARIN SODIUM profile page.

The generic ingredient in HEPARIN SODIUM is heparin sodium. There are seventy-seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.

Summary for 206552

Tradename:	HEPARIN SODIUM
Applicant:	Fresenius Kabi Usa
Ingredient:	heparin sodium
Patents:	0

Pharmacology for NDA: 206552

Suppliers and Packaging for NDA: 206552

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HEPARIN SODIUM	heparin sodium	INJECTABLE;INJECTION	206552	ANDA	Fresenius Kabi USA, LLC	76045-108	76045-108-10	24 BLISTER PACK in 1 CARTON (76045-108-10) / 1 SYRINGE, GLASS in 1 BLISTER PACK (76045-108-00) / 1 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5,000 UNITS/ML
Approval Date:	Jun 10, 2016	TE:	AP	RLD:	No

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