Is there a generic for Cimetidine?

Yes. The FDA Orange Book lists 30 approved generic (ANDA) applications for Cimetidine, referencing the brand TAGAMET HB. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Cimetidine?

TAGAMET HB (NDA 020238, MEDTECH PRODUCTS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Cimetidine are approved?

Cimetidine is approved in the following dosage forms: suspension, tablet.

FDA Orange Book · active-ingredient family

Cimetidine

Cimetidine: 3 brands, 30 generics; first approved Dec 14, 1983; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 30 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

TAGAMET HBRLD

MEDTECH PRODUCTSNDA 02023819952 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
200MG	TABLET	ORAL	OTC	—

TAGAMETRLD

GLAXOSMITHKLINENDA 017920—4 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
800MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—

TAGAMET HB 200

GLAXOSMITHKLINENDA 0209511999

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/20ML	SUSPENSION	ORAL	Discontinued	—

Abbreviated applications

Generic (ANDA) products (30)

CIMETIDINE

AUROBINDO PHARMA LTDANDA 21899720244 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Rx	AB
300MG	TABLET	ORAL	Rx	AB
400MG	TABLET	ORAL	Rx	AB
800MG	TABLET	ORAL	Rx	AB

CIMETIDINE

BIONPHARMAANDA 21822020244 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Rx	AB
300MG	TABLET	ORAL	Rx	AB
400MG	TABLET	ORAL	Rx	AB
800MG	TABLET	ORAL	Rx	AB

CIMETIDINE

WATSON LABS TEVAANDA 0754251999

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

IVAX SUB TEVA PHARMSANDA 0753451999

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

HIKMAANDA 07489019984 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	—
300MG	TABLET	ORAL	Discontinued	—
400MG	TABLET	ORAL	Discontinued	—
800MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

L PERRIGO COANDA 0752851998

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	OTC	—

CIMETIDINE

APOTEXANDA 07494819982 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Discontinued	—
200MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

CONTRACT PHARMACALANDA 0749611998

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

CONTRACT PHARMACALANDA 0749631998

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

PERRIGOANDA 0749721998

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

SANDOZANDA 07512219982 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	ORAL	Discontinued	—
200MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

PLIVAANDA 07456819973 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	—
300MG	TABLET	ORAL	Discontinued	—
400MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

PLIVAANDA 0745661997

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
800MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

WATSON LABS INCANDA 07434919963 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	—
300MG	TABLET	ORAL	Discontinued	—
400MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

WATSON LABS INCANDA 0743161996

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
800MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

UPSHER SMITH LABSANDA 07450619964 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	—
300MG	TABLET	ORAL	Discontinued	—
400MG	TABLET	ORAL	Discontinued	—
800MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

IVAX SUB TEVA PHARMSANDA 07442419954 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	—
300MG	TABLET	ORAL	Discontinued	—
400MG	TABLET	ORAL	Discontinued	—
800MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

SANDOZANDA 07425019954 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	—
300MG	TABLET	ORAL	Discontinued	—
400MG	TABLET	ORAL	Discontinued	—
800MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

NOVITIUM PHARMAANDA 07434019952 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG	TABLET	ORAL	Discontinued	—
400MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

NOVITIUM PHARMAANDA 0743391995

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
800MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

IVAX SUB TEVA PHARMSANDA 07440119953 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	—
300MG	TABLET	ORAL	Discontinued	—
400MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

IVAX SUB TEVA PHARMSANDA 0744021995

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
800MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

TEVAANDA 07436519954 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	—
300MG	TABLET	ORAL	Discontinued	—
400MG	TABLET	ORAL	Discontinued	—
800MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

CHARTWELL RXANDA 07410019954 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Discontinued	—
300MG	TABLET	ORAL	Discontinued	—
400MG	TABLET	ORAL	Discontinued	—
800MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

CYCLEANDA 07436119942 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
300MG	TABLET	ORAL	Discontinued	—
400MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

CYCLEANDA 0743711994

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
800MG	TABLET	ORAL	Discontinued	—

CIMETIDINE

CHARTWELL MOLECULESANDA 07432919944 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
800MG	TABLET	ORAL	Rx	AB
200MG	TABLET	ORAL	Rx	AB
300MG	TABLET	ORAL	Rx	AB
400MG	TABLET	ORAL	Rx	AB

CIMETIDINE

MYLANANDA 07424619944 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Rx	AB
300MG	TABLET	ORAL	Rx	AB
400MG	TABLET	ORAL	Rx	AB
800MG	TABLET	ORAL	Rx	AB

CIMETIDINE

TEVAANDA 07415119943 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	ORAL	Rx	AB
300MG	TABLET	ORAL	Rx	AB
400MG	TABLET	ORAL	Rx	AB

CIMETIDINE

TEVAANDA 0744631994

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
800MG	TABLET	ORAL	Rx	AB

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 14, 1983

43 yr 2 mo ago

Most recent approval

Nov 12, 2024

1 yr 8 mo ago

Approvals span 1983–2024 across 33 FDA applications.

Brand (NDA) 39%

Generic (ANDA) 3091%

Cimetidine — 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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