Last Updated: May 3, 2026

Details for New Drug Application (NDA): 091682

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NDA 091682 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 091682

Tradename:	HEPARIN SODIUM
Applicant:	Plano Pharms
Ingredient:	heparin sodium
Patents:	0

Pharmacology for NDA: 091682

Suppliers and Packaging for NDA: 091682

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HEPARIN SODIUM	heparin sodium	INJECTABLE;INJECTION	091682	ANDA	Plano Pharmaceuticals Inc.	87188-102	87188-102-90	25 VIAL, MULTI-DOSE in 1 CARTON (87188-102-90) / 1 mL in 1 VIAL, MULTI-DOSE (87188-102-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1,000 UNITS/ML
Approval Date:	Jun 8, 2011	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5,000 UNITS/ML
Approval Date:	Jun 8, 2011	TE:	AP	RLD:	No

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