Last Updated: September 24, 2026

Details for New Drug Application (NDA): 065345

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NDA 065345 describes CEFAZOLIN SODIUM, which is a drug marketed by Abraxis Pharm, Acs Dobfar, Aurobindo Pharma, Bedford, Cephazone Pharma, Dr Reddys, Facta Farma, Fresenius Kabi Usa, Glaxosmithkline, Hikma, Hikma Farmaceutica, Hospira, Hospira Inc, Qilu Antibiotics, Samson Medcl, Sandoz, Steri Pharma, Teva Pharms, and Hq Spclt Pharma, and is included in thirty-four NDAs. It is available from sixteen suppliers. Additional details are available on the CEFAZOLIN SODIUM profile page.

The generic ingredient in CEFAZOLIN SODIUM is cefazolin sodium. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.

Summary for 065345

Tradename:	CEFAZOLIN SODIUM
Applicant:	Sandoz
Ingredient:	cefazolin sodium
Patents:	0

Pharmacology for NDA: 065345

Medical Subject Heading (MeSH) Categories for 065345

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 065345

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFAZOLIN SODIUM	cefazolin sodium	INJECTABLE;INJECTION	065345	ANDA	Hospira, Inc	0409-2585	0409-2585-01	25 VIAL in 1 CARTON (0409-2585-01) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0409-2585-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL
Approval Date:	May 9, 2007	TE:		RLD:	No

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