Is there a generic for Cefazolin sodium?

Yes. The FDA Orange Book lists 35 approved generic (ANDA) applications for Cefazolin sodium, referencing the brand CEFAZOLIN SODIUM. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Cefazolin sodium?

CEFAZOLIN SODIUM (NDA 211413, HQ SPCLT PHARMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Cefazolin sodium are approved?

Cefazolin sodium is approved in the following dosage forms: injectable, powder, solution.

FDA Orange Book · active-ingredient family

Cefazolin sodium

Cefazolin sodium: 6 brands, 35 generics; first approved Jun 08, 1983; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 35 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

CEFAZOLIN SODIUMRLDRS

HQ SPCLT PHARMANDA 21141320232 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2GM BASE/VIAL	POWDER	INTRAVENOUS	Rx	—
EQ 3GM BASE/VIAL	POWDER	INTRAVENOUS	Rx	—

CEFAZOLIN SODIUMRLDRS

HIKMANDA 21610920222 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2GM BASE/VIAL	POWDER	INTRAVENOUS	Rx	—
EQ 3GM BASE/VIAL	POWDER	INTRAVENOUS	Rx	—

CEFAZOLIN IN DEXTROSERLDRS

BAXTER HLTHCARE CORPNDA 20713120213 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	—
EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	—
EQ 3GM BASE/150ML (EQ 20MG BASE/ML)	SOLUTION	INTRAVENOUS	Rx	—

CEFAZOLIN AND DEXTROSERLDRS

B BRAUNNDA 05077920004 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Rx	—
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Rx	—
EQ 3GM BASE/VIAL	INJECTABLE	INJECTION	Rx	—

ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINERRLD

BAXTER HLTHCARENDA 05056619834 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—
EQ 20MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—
EQ 20MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

ANCEFRLD

GLAXOSMITHKLINENDA 050461—5 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
EQ 5GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—

Abbreviated applications

Generic (ANDA) products (35)

CEFAZOLIN SODIUMRS

QILU ANTIBIOTICSANDA 2092172018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

CEFAZOLIN SODIUM

HOSPIRAANDA 2016542016

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

QILU ANTIBIOTICSANDA 20366120153 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP
EQ 2GM BASE/VIAL	INJECTABLE	INJECTION	Rx	—
EQ 3GM BASE/VIAL	INJECTABLE	INJECTION	Rx	—

CEFAZOLIN SODIUM

CEPHAZONE PHARMAANDA 06528020092 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

CEPHAZONE PHARMAANDA 0652952009

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

CEPHAZONE PHARMAANDA 0652962009

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 20GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

ACS DOBFARANDA 06530320082 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

CEFAZOLIN SODIUM

ACS DOBFARANDA 06530620082 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP
EQ 20GM BASE/VIAL	INJECTABLE	INJECTION	Rx	—

CEFAZOLIN SODIUM

AUROBINDO PHARMAANDA 06539520082 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

SANDOZANDA 0653452007

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUMRS

SAMSON MEDCLANDA 06514120062 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100GM BASE/VIAL	INJECTABLE	INJECTION	Rx	—
EQ 300GM BASE/VIAL	INJECTABLE	INJECTION	Rx	—

CEFAZOLIN SODIUM

HOSPIRA INCANDA 0652442005

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

HOSPIRA INCANDA 0652472005

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

HOSPIRA INCANDA 06522620052 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

HIKMA FARMACEUTICAANDA 0651432004

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

CEFAZOLIN SODIUMRS

HIKMA FARMACEUTICAANDA 06504720012 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

CEFAZOLIN SODIUM

FRESENIUS KABI USAANDA 06416919982 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

FRESENIUS KABI USAANDA 06417019982 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—
EQ 20GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

GLAXOSMITHKLINEANDA 0640331993

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

FACTA FARMAANDA 0632071991

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

FACTA FARMAANDA 06320919912 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 20GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

FACTA FARMAANDA 0632141991

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

STERI PHARMAANDA 0632081991

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

STERI PHARMAANDA 0632161991

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

ANCEF IN PLASTIC CONTAINER

BAXTER HLTHCAREANDA 06300219912 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—
EQ 20MG BASE/ML	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

TEVA PHARMSANDA 06301819902 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 5GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

DR REDDYSANDA 06298819893 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

DR REDDYSANDA 06298919893 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 5GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 20GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

TEVA PHARMSANDA 06301619893 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

SANDOZANDA 06283119883 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Rx	AP
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Rx	AP

CEFAZOLIN SODIUM

BEDFORDANDA 06289419885 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 5GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

HIKMAANDA 06280719886 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 5GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 20GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

CEFAZOLIN SODIUM

ABRAXIS PHARMANDA 06268819864 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 20GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

KEFZOL

LILLYANDA 06255719852 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

KEFZOL

ACS DOBFARANDA 061773—5 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 500MG BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 1GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 10GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—
EQ 20GM BASE/VIAL	INJECTABLE	INJECTION	Discontinued	—

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Jun 08, 1983

43 yr 9 mo ago

Most recent approval

Aug 26, 2024

1 yr 11 mo ago

Approvals span 1983–2024 across 41 FDA applications.

Brand (NDA) 615%

Generic (ANDA) 3585%

Cefazolin sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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