Is there a generic for Cephalexin?

Yes. The FDA Orange Book lists 54 approved generic (ANDA) applications for Cephalexin, referencing the brand KEFLET. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Cephalexin?

KEFLET (NDA 050440, LILLY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Cephalexin are approved?

Cephalexin is approved in the following dosage forms: capsule, for suspension, tablet, tablet, for suspension.

FDA Orange Book · active-ingredient family

Cephalexin

Cephalexin: 3 brands, 54 generics; first approved Dec 01, 1986; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 54 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

KEFLETRLD

LILLYNDA 05044019873 strengths

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EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—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EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—

KEFLEXRLD

PRAGMANDA 050405—4 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE	ORAL	Discontinued	—
EQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE	ORAL	Discontinued	—
EQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE	ORAL	Discontinued	—
EQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE	ORAL	Discontinued	—

KEFLEXRLD

PRAGMANDA 050406—3 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 125MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION	ORAL	Discontinued	—
EQ 250MG BASE/5ML *Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION	ORAL	Discontinued	—
EQ 100MG BASE/ML *Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (54)

CEPHALEXIN

AUROBINDO PHARMAANDA 21356820262 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 125MG BASE/5ML	FOR SUSPENSION	ORAL	Rx	AB
EQ 250MG BASE/5ML	FOR SUSPENSION	ORAL	Rx	AB

CEPHALEXIN

ALKEM LABS LTDANDA 21894720242 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Rx	AB
EQ 500MG BASE	TABLET	ORAL	Rx	AB

CEPHALEXIN

AUROBINDO PHARMA LTDANDA 21881720242 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Rx	AB
EQ 500MG BASE	TABLET	ORAL	Rx	AB

CEPHALEXIN

ALKEM LABS LTDANDA 21022120192 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 125MG BASE/5ML	FOR SUSPENSION	ORAL	Rx	AB
EQ 250MG BASE/5ML	FOR SUSPENSION	ORAL	Rx	AB

CEPHALEXIN

ALKEM LABS LTDANDA 09083620104 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Rx	AB
EQ 500MG BASE	CAPSULE	ORAL	Rx	AB
EQ 333MG BASE	CAPSULE	ORAL	Rx	—
EQ 750MG BASE	CAPSULE	ORAL	Rx	AB

CEPHALEXIN

HIKMA PHARMSANDA 06544420092 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 125MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—
EQ 250MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—

CEPHALEXIN

YUNG SHIN PHARMANDA 06533620072 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 125MG BASE/5ML	FOR SUSPENSION	ORAL	Rx	AB
EQ 250MG BASE/5ML	FOR SUSPENSION	ORAL	Rx	AB

CEPHALEXIN

CHARTWELL RXANDA 06532620062 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 125MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—
EQ 250MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—

CEPHALEXIN

HIKMAANDA 06521520062 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

LUPINANDA 06522920052 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Rx	AB
EQ 500MG BASE	CAPSULE	ORAL	Rx	AB

CEPHALEXIN

AUROBINDO PHARMAANDA 06525320053 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Rx	AB
EQ 500MG BASE	CAPSULE	ORAL	Rx	AB
EQ 750MG BASE	CAPSULE	ORAL	Rx	AB

CEPHALEXIN

LUPINANDA 06523420052 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 125MG BASE/5ML	FOR SUSPENSION	ORAL	Rx	AB
EQ 250MG BASE/5ML	FOR SUSPENSION	ORAL	Rx	AB

CEPHALEXIN

ANDA REPOSITORYANDA 06524820052 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Rx	AB
EQ 500MG BASE	CAPSULE	ORAL	Rx	AB

CEPHALEXIN

CHARTWELL RXANDA 06515220052 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Rx	AB
EQ 500MG BASE	CAPSULE	ORAL	Rx	AB

PANIXINE DISPERDOSE

RANBAXY LABS LTDANDA 06510020032 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET, FOR SUSPENSION	ORAL	Discontinued	—
EQ 125MG BASE	TABLET, FOR SUSPENSION	ORAL	Discontinued	—

CEPHALEXIN

SUN PHARM INDS LTDANDA 06508120012 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 125MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—
EQ 250MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—

CEPHALEXIN

SUN PHARM INDS LTDANDA 06500719992 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

APOTHECONANDA 06318619942 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

APOTHECONANDA 0629861991

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 125MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—

CEPHALEXIN

APOTHECONANDA 06306319892 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

APOTHECONANDA 0629871989

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—

CEPHALEXIN

TEVAANDA 06302419892 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE	TABLET	ORAL	Rx	—
EQ 250MG BASE	TABLET	ORAL	Rx	—

CEPHALEXIN

APOTHECONANDA 0629741988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

APOTHECONANDA 0629731988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

VITARINEANDA 06286319883 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Discontinued	—
EQ 500MG BASE	TABLET	ORAL	Discontinued	—
EQ 1GM BASE	TABLET	ORAL	Discontinued	—

CEPHALEXIN

AJENAT PHARMSANDA 06271319882 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Rx	AB
EQ 500MG BASE	CAPSULE	ORAL	Rx	AB

CEPHALEXIN

YOSHITOMIANDA 0628711988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

YOSHITOMIANDA 0628721988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

TEVAANDA 0628731988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 125MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—

CEPHALEXIN

TEVAANDA 0628671988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—

CEPHALEXIN

STEVENS JANDA 0628701988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

STEVENS JANDA 0628691988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

TEVAANDA 0628211988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

TEVAANDA 0628231988

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

VITARINEANDA 0627791987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 125MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—

CEPHALEXIN

VITARINEANDA 0627811987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—

CEPHALEXIN

BARRANDA 0628261987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Discontinued	—

CEPHALEXIN

BARRANDA 0628271987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE	TABLET	ORAL	Discontinued	—

CEPHALEXIN

BARRANDA 0627781987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 125MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—

CEPHALEXIN

BARRANDA 0627771987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—

CEPHALEXIN

BARRANDA 0627731987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

TEVAANDA 0627671987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 125MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—

CEPHALEXIN

TEVAANDA 0627681987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE/5ML	FOR SUSPENSION	ORAL	Discontinued	—

CEPHALEXIN

SUN PHARM INDS (IN)ANDA 06279119872 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

TEVAANDA 0627601987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

TEVAANDA 0627611987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

BARRANDA 0627751987

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

PUREPAC PHARMANDA 06280919872 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

TEVAANDA 06270219872 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Rx	AB
EQ 500MG BASE	CAPSULE	ORAL	Rx	AB

CEPHALEXIN

TEVAANDA 06270319872 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 125MG BASE/5ML	FOR SUSPENSION	ORAL	Rx	AB
EQ 250MG BASE/5ML	FOR SUSPENSION	ORAL	Rx	AB

KEFLET

LILLYANDA 06274519862 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	TABLET	ORAL	Discontinued	—
EQ 500MG BASE	TABLET	ORAL	Discontinued	—

CEPHALEXIN

FACTA FARMAANDA 062118—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

IVAX SUB TEVA PHARMSANDA 061969—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 250MG BASE	CAPSULE	ORAL	Discontinued	—
EQ 500MG BASE	CAPSULE	ORAL	Discontinued	—

CEPHALEXIN

FACTA FARMAANDA 062117—3 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 100MG BASE/ML *Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION	ORAL	Discontinued	—
EQ 125MG BASE/5ML *Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION	ORAL	Discontinued	—
EQ 250MG BASE/5ML *Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION	ORAL	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

Dec 01, 1986

40 yr 2 mo ago

Most recent approval

Jun 09, 2026

1 mo ago

Approvals span 1986–2026 across 57 FDA applications.

Brand (NDA) 35%

Generic (ANDA) 5495%

Cephalexin — 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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