FDA Orange Book · active-ingredient family
Famotidine
Famotidine: 10 brands, 90 generics; first approved Oct 15, 1986; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 90 ANDA applications approved.
Brands (NDA)
10
Generics (ANDA)
90
Listed patents
0
Presentations
143
Brand (NDA) products
Originator applications
- FAMOTIDINERLDRSSAGENTNDA 21993520253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG/5ML (4MG/ML) SOLUTION INTRAVENOUS Rx — 40MG/10ML (4MG/ML) SOLUTION INTRAVENOUS Rx — 200MG/50ML (4MG/ML) SOLUTION INTRAVENOUS Rx — - PEPCID ACRLDKENVUE BRANDSNDA 02080119982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, CHEWABLE ORAL Discontinued — 20MG TABLET, CHEWABLE ORAL OTC — - PEPCID RPDRLDMERCKNDA 02075219982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 40MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - PEPCID ACRLDKENVUE BRANDSNDA 02032519952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — 20MG TABLET ORAL OTC — - MERCK SHARP DOHMENDA 0202491994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/ML INJECTABLE INJECTION Discontinued — - PEPCIDRLDSALIX PHARMSNDA 0195271987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Discontinued — - PEPCIDRLDMERCKNDA 01951019862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — 10MG/ML INJECTABLE INJECTION Discontinued — - PEPCIDRLDBAUSCHNDA 01946219862 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - UCB INCNDA 02171220042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 40MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - J AND J CONSUMER INCNDA 0209021999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued —
Generic (ANDA) products (90)
Abbreviated applications
- FAMOTIDINELUPINANDA 2174322026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - FAMOTIDINECONTRACT PHARMACALANDA 2196032026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Rx AB - FAMOTIDINEMSNANDA 2198632025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Rx AB - FAMOTIDINEAUROBINDO PHARMA LTDANDA 2190912025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Rx AB - FAMOTIDINEBIONPHARMAANDA 2191532025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Discontinued — - FAMOTIDINELANNETT CO INCANDA 2179822025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Rx AB - FAMOTIDINEREGCON HOLDINGSANDA 21863120252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FAMOTIDINEEPIC PHARMA LLCANDA 2183442024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Rx AB - FAMOTIDINEMSNANDA 21740020242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FAMOTIDINECONTRACT PHARMACALANDA 21800320242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — 20MG TABLET ORAL OTC — - FAMOTIDINEGRAVITI PHARMSANDA 21846120242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — 20MG TABLET ORAL OTC — - FAMOTIDINEUNICHEMANDA 2176052024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Rx AB - FAMOTIDINERISINGANDA 21818120232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FAMOTIDINECONTRACT PHARMACALANDA 21766920232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FAMOTIDINEAJANTA PHARMA LTDANDA 2175292023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Rx AB - FAMOTIDINEMICRO LABSANDA 2178422023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Rx AB - FAMOTIDINEANNORA PHARMAANDA 2173302023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Rx AB - FAMOTIDINECARNEGIEANDA 2171372023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Rx AB - FAMOTIDINESOMERSET THERAPS LLCANDA 2176552023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Rx AB - FAMOTIDINEALKEM LABS LTDANDA 2164002023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Rx AB - FAMOTIDINEALKEM LABS LTDANDA 21737520232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FAMOTIDINEMARKSANS PHARMAANDA 21754320232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — 20MG TABLET ORAL OTC — - FAMOTIDINEZYDUS PHARMSANDA 2158282022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - FAMOTIDINEAMNEALANDA 2164272022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Rx AB - FAMOTIDINEZYDUS PHARMSANDA 21644120222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FAMOTIDINEVKT PHARMAANDA 21582220222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — 20MG TABLET ORAL OTC — - FAMOTIDINEVKT PHARMAANDA 21563020222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FAMOTIDINEANNORA PHARMAANDA 21576620212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — 20MG TABLET ORAL OTC — - FAMOTIDINEANNORA PHARMAANDA 21576720212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FAMOTIDINEASCENT PHARMS INCANDA 21603020212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — 20MG TABLET ORAL OTC — - FAMOTIDINEASCENT PHARMS INCANDA 21568920212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FAMOTIDINERSNOVITIUM PHARMAANDA 2150432021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Rx AB - FAMOTIDINEAUROBINDO PHARMAANDA 20653120162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — 20MG TABLET ORAL OTC — - FAMOTIDINEAUROBINDO PHARMA LTDANDA 20653020152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FAMOTIDINENOVITIUM PHARMAANDA 2019952014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Rx AB - FAMOTIDINENOVEL LABS INCANDA 2016952012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Rx AB - FAMOTIDINEGLENMARK PHARMSANDA 0908372010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL OTC — - FAMOTIDINELUPIN LTDANDA 0904402010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Rx AB - FAMOTIDINENAVINTA LLCANDA 0910202010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/5ML FOR SUSPENSION ORAL Rx AB - FAMOTIDINESUN PHARM INDS LTDANDA 09028320092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — - FAMOTIDINEALEMBIC PHARMS LTDANDA 07891620092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FAMOTIDINEMYLAN LABS LTDANDA 0786412008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - MYLAN LABS LTDANDA 0786422008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - FAMOTIDINEPERRIGO R AND DANDA 0773512006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL OTC — - FAMOTIDINEPERRIGO R AND DANDA 07735220052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — - FAMOTIDINEPERRIGOANDA 0754002005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — - FAMOTIDINEGLENMARK PHARMSANDA 0771462005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — - FAMOTIDINEPERRIGOANDA 0757152003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, CHEWABLE ORAL Discontinued — - EPIC PHARMA LLCANDA 0763242002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - EPIC PHARMA LLCANDA 0763222002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - FAMOTIDINESANDOZANDA 0761012002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - FAMOTIDINEAPOTEX INCANDA 0759422002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - FAMOTIDINEHIKMAANDA 0757992002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - HIKMAANDA 0757892002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - FAMOTIDINEAPOTEXANDA 0756102002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - FAMOTIDINENATCO PHARMAANDA 0756742001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - ABBVIEANDA 0757292001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/ML INJECTABLE INJECTION Discontinued — - FAMOTIDINESUN PHARM INDUSTRIESANDA 07563920012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — - FAMOTIDINEWATSON LABSANDA 0754042001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - FAMOTIDINEHOSPIRAANDA 0758702001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - FAMOTIDINEHOSPIRAANDA 0759052001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - FAMOTIDINEACTAVIS ELIZABETHANDA 07565020012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - FAMOTIDINEDR REDDYS LABS LTDANDA 07736720012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — - FAMOTIDINEP AND LANDA 0755122001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — - FAMOTIDINEAPOTEXANDA 07561120012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - FAMOTIDINETEVAANDA 0753122001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — - BAXTER HLTHCAREANDA 0755912001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.4MG/ML INJECTABLE INJECTION Rx — - FAMOTIDINESANDOZANDA 07560720012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - FAMOTIDINEMYLAN PHARMS INCANDA 07545720012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - SAGENTANDA 0758252001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - FAMOTIDINEAPOTHECONANDA 0757072001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - FAMOTIDINEFRESENIUS KABI USAANDA 0757092001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - FAMOTIDINERSHIKMAANDA 0754882001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - FAMOTIDINEHOSPIRAANDA 0757052001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - FAMOTIDINESAGENTANDA 0756512001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - FAMOTIDINESAGENTANDA 0756842001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - APOTHECONANDA 0757082001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - FRESENIUS KABI USAANDA 0758132001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - HIKMAANDA 0754862001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - HOSPIRAANDA 0756692001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued — - SAGENTANDA 0756222001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - FAMOTIDINECARLSBADANDA 07580520012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FAMOTIDINECHARTWELL RXANDA 07578620012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FAMOTIDINEDR REDDYS LABS LTDANDA 07571820012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FAMOTIDINEIVAX SUB TEVA PHARMSANDA 07551120012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FAMOTIDINEMANKIND PHARMAANDA 07530220012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FAMOTIDINERISINGANDA 07570420012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FAMOTIDINESANDOZANDA 07579320012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - FAMOTIDINETEVAANDA 07531120012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - FAMOTIDINEWATSON LABSANDA 07506220012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
40 yr 5 mo ago
Most recent approval
4 mo ago
Approvals span 1986–2026 across 100 FDA applications.
Brand (NDA) 1010%
Generic (ANDA) 9090%
Famotidine: 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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
