Famotidine

Treats pathological hypersecretory conditions. Sold as Pepcid, Pepcid Preservative Free, Pepcid Preservative Free In Plastic Container, Pepcid Ac, Pepcid Rpd and 2 more. Every FDA application for this active ingredient: 10 branded and 93 generic.

As of Nov 15, 2026, FDA lists 103 applications for Famotidine (sold as Pepcid, Pepcid Preservative Free, Pepcid Preservative Free In Plastic Container and others), first approved Oct 15, 1986, with 10 new uses approved and 0 published complete response letters.

First approved: Oct 15, 1986
Applications: 103
New uses approved: 10
Complete response letters: 0
Medicare spending, 2025: $943K

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Pepcid	Part D	$831K	+5%	186
FAMOTIDINE	Part B	$113K	New	38,334

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

FAMOTIDINE 20 MG TABLET: $0.028 per unitGeneric · -2% in a year
FAMOTIDINE 20 MG/2 ML VIAL: $0.303 per MLGeneric · new this year
FAMOTIDINE 40 MG TABLET: $0.048 per unitGeneric · -9% in a year
FAMOTIDINE 40 MG/5 ML SUSP: $0.127 per MLGeneric · -38% in a year

Clinical Trials

24 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Dexamethasone De-Escalation in Neoadjuvant Chemoimmunotherapy for Triple-Negative Breast CancerTriple Negative Breast Cancer, Triple Negative Breast Cancer (TNBC) · Washington University School of Medicine	Phase 2	Not yet recruiting	Nov 3, 2026
Combination Therapy With Danazol, Prednisolone, and Thalidomide for Thalidomide-Refractory Transfusion-Dependent β-ThalassemiaBeta-Thalassemia, Thalassemia · Khyber Medical University Peshawar	Phase 3	Recruiting	Oct 21, 2026
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2Functional Gastrointestinal Disorders · Buddhist Tzu Chi General Hospital	Phase 2	Recruiting	Oct 5, 2026
Study on the Effect of Famotidine on Pharmacokinetics of TaletrectinibHealthy Adult Participants · Nuvation Bio Inc.	Phase 1	Not yet recruiting	Aug 3, 2026
Single and Multiple Dose Study to Evaluate Safety and Pharmacokinetics of BMS-986533 in Healthy Participants and Assessments of Food and pH Effects on Relative Bioavailability, and Drug-Drug Interaction Potential in Healthy ParticipantsHealthy Volunteers · Bristol-Myers Squibb	Phase 1	Recruiting	Jun 5, 2026
Paracetamol and Ibuprofen With or Without Famotidine for Calcific Tendinitis of the ShoulderCalcific Tendinitis · University Hospital Dubrava	Not applicable	Not yet recruiting	Apr 20, 2026
IMPOWER-QoL: IMPact Of Discontinuing Premedication for WEekly Paclitaxel on bReast Cancer Patient's Quality Of LifeBreast Cancer · Charles LeMoyne Hospital	Not applicable	Not yet recruiting	Mar 17, 2026
An Open-Label, Single-Arm, Dose-Escalation Phase I Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of EDB-102 in Patients With EGFR L858R-Mutant, Third-Generation TKI-Resistant Advanced Non-Small Cell Lung Cancer With Liver MetastasesNon-Small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer · Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Phase 1	Not yet recruiting	Mar 10, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Oct 15, 1986	PepcidNDA 19462 · New molecular entity	Bausch	35	Discontinued
Nov 4, 1986	Pepcid, Pepcid Preservative FreeNDA 19510 · New dosage form	Merck	29	Discontinued
Feb 2, 1987	PepcidNDA 19527 · New dosage form	Salix Pharms	26	Discontinued
Feb 18, 1994	Pepcid Preservative Free In Plastic ContainerNDA 20249 · New dosage form	Merck Sharp Dohme	13	Discontinued
Apr 28, 1995	Pepcid AcNDA 20325 · New formulation or manufacturer	Kenvue Brands	27	Marketed
May 28, 1998	Pepcid RpdNDA 20752 · New dosage form	Merck	6	Discontinued
Sep 24, 1998	Pepcid AcNDA 20801 · New dosage form	Kenvue Brands	11	Marketed
Aug 5, 1999	Pepcid AcNDA 20902 · New dosage form	J And J Consumer Inc	4	Discontinued
Apr 16, 2001	FamotidineANDA 75062	Watson Labs	0	Discontinued
Apr 16, 2001	FamotidineANDA 75302	Mankind Pharma	1	Marketed
Apr 16, 2001	FamotidineANDA 75311	Teva	1	Discontinued
Apr 16, 2001	Famotidine Preservative FreeANDA 75486	Hikma	3	Marketed
Apr 16, 2001	FamotidineANDA 75488	Hikma	2	Marketed
Apr 16, 2001	FamotidineANDA 75511	Ivax Sub Teva Pharms	8	Marketed
Apr 16, 2001	Famotidine Preservative FreeANDA 75622	Sagent	3	Marketed
Apr 16, 2001	FamotidineANDA 75651	Sagent	2	Marketed
Apr 16, 2001	Famotidine Preservative FreeANDA 75669	Hospira	1	Discontinued
Apr 16, 2001	FamotidineANDA 75684	Sagent	2	Marketed
Apr 16, 2001	FamotidineANDA 75704	Rising	5	Marketed
Apr 16, 2001	FamotidineANDA 75705	Hospira	1	Discontinued
Apr 16, 2001	FamotidineANDA 75709	Fresenius Kabi USA	2	Marketed
Apr 16, 2001	FamotidineANDA 75718	Dr Reddys Labs Ltd	7	Marketed
Apr 16, 2001	FamotidineANDA 75786	Chartwell Rx	3	Marketed
Apr 16, 2001	FamotidineANDA 75793	Sandoz	0	Discontinued
Apr 16, 2001	FamotidineANDA 75805	Carlsbad	3	Marketed
Apr 16, 2001	Famotidine Preservative FreeANDA 75813	Fresenius Kabi USA	2	Marketed
Apr 17, 2001	Famotidine Preservative FreeANDA 75825	Sagent	0	Marketed
Apr 18, 2001	FamotidineANDA 75457	Mylan Pharms Inc	0	Discontinued
May 10, 2001	Famotidine Preservative Free In Plastic ContainerANDA 75591	Baxter Hlthcare	3	Marketed
May 10, 2001	FamotidineANDA 75607	Sandoz	1	Discontinued
May 31, 2001	FamotidineANDA 75312	Teva	2	Discontinued
Jul 23, 2001	FamotidineANDA 75611	Apotex	4	Discontinued
Jul 26, 2001	FamotidineANDA 75512	P And L	7	Marketed
Sep 14, 2001	FamotidineANDA 75650	Actavis Elizabeth	2	Discontinued
Nov 23, 2001	FamotidineANDA 75870	Hospira	0	Discontinued
Nov 23, 2001	FamotidineANDA 75905	Hospira	0	Discontinued
Nov 28, 2001	FamotidineANDA 75404	Watson Labs	0	Discontinued
Dec 12, 2001	FamotidineANDA 75639	Sun Pharm Industries	4	Discontinued
Dec 17, 2001	Famotidine Preservative Free In Plastic ContainerANDA 75729	Abbvie	0	Discontinued
Dec 21, 2001	FamotidineANDA 75674	Natco Pharma	0	Discontinued
Mar 12, 2002	FamotidineANDA 75610	Apotex	3	Discontinued
Apr 30, 2002	Famotidine Preservative FreeANDA 75789	Hikma	0	Discontinued
Apr 30, 2002	FamotidineANDA 75799	Hikma	0	Discontinued
Aug 2, 2002	FamotidineANDA 75942	Apotex Inc	2	Discontinued
Oct 21, 2002	FamotidineANDA 76101	Sandoz	0	Discontinued
Nov 27, 2002	Famotidine Preservative FreeANDA 76322	Epic Pharma LLC	1	Discontinued
Nov 27, 2002	Famotidine Preservative FreeANDA 76324	Epic Pharma LLC	1	Discontinued
Aug 22, 2003	FamotidineANDA 75715	Perrigo	1	Discontinued
Sep 24, 2004	FluxidNDA 21712 · New dosage form	Ucb Inc	0	Discontinued
Mar 7, 2005	FamotidineANDA 77146	Glenmark Pharms	0	Marketed
Mar 18, 2005	FamotidineANDA 75400	Perrigo	4	Marketed
Jul 27, 2005	FamotidineANDA 77352	Perrigo R And D	0	Discontinued
Sep 25, 2006	FamotidineANDA 77351	Perrigo R And D	3	Marketed
Sep 25, 2006	FamotidineANDA 77367	Dr Reddys Labs Ltd	1	Marketed
Jun 25, 2008	FamotidineANDA 78641	Mylan Labs Ltd	1	Marketed
Jun 25, 2008	Famotidine Preservative FreeANDA 78642	Mylan Labs Ltd	1	Marketed
May 22, 2009	FamotidineANDA 78916	Alembic Pharms Ltd	4	Marketed
Nov 17, 2009	FamotidineANDA 90283	Sun Pharm Inds Ltd	2	Discontinued
May 27, 2010	FamotidineANDA 91020	Navinta LLC	0	Marketed
Jun 29, 2010	FamotidineANDA 90440	Lupin Ltd	1	Marketed
Aug 4, 2010	FamotidineANDA 90837	Glenmark Pharms	0	Marketed
Dec 17, 2012	FamotidineANDA 201695	Novel Labs Inc	0	Marketed
May 30, 2014	FamotidineANDA 201995	Novitium Pharma	1	Marketed
Dec 22, 2015	FamotidineANDA 206530	Aurobindo Pharma Ltd	2	Marketed
Apr 26, 2016	FamotidineANDA 206531	Aurobindo Pharma	4	Marketed
Apr 20, 2021	FamotidineANDA 215043	Novitium Pharma	0	Marketed
Oct 15, 2021	FamotidineANDA 215689	Ascent Pharms Inc	0	Marketed
Nov 3, 2021	FamotidineANDA 216030	Ascent Pharms Inc	0	Marketed
Nov 4, 2021	FamotidineANDA 215767	Annora Pharma	0	Marketed
Nov 8, 2021	FamotidineANDA 215766	Annora Pharma	0	Marketed
Jan 7, 2022	FamotidineANDA 215630	Vkt Pharma	1	Marketed
Jan 28, 2022	FamotidineANDA 215822	Vkt Pharma	1	Marketed
Jun 3, 2022	FamotidineANDA 216441	Zydus Pharms	0	Marketed
Aug 4, 2022	FamotidineANDA 216427	Amneal	0	Marketed
Nov 22, 2022	FamotidineANDA 215828	Zydus Pharms	0	Discontinued
Mar 8, 2023	FamotidineANDA 217543	Pharmazone	0	Marketed
Apr 24, 2023	FamotidineANDA 217375	Alkem Labs Ltd	0	Marketed
May 15, 2023	FamotidineANDA 216400	Alkem Labs Ltd	0	Marketed
Jun 16, 2023	FamotidineANDA 217655	Somerset Theraps LLC	1	Marketed
Jul 7, 2023	FamotidineANDA 217137	Carnegie	0	Marketed
Aug 17, 2023	FamotidineANDA 217330	Annora Pharma	0	Marketed
Sep 14, 2023	FamotidineANDA 217842	Micro Labs	0	Marketed
Sep 18, 2023	FamotidineANDA 217529	Ajanta Pharma Ltd	0	Marketed
Dec 20, 2023	FamotidineANDA 217669	Contract Pharmacal	0	Marketed
Dec 22, 2023	FamotidineANDA 218181	Rising	0	Marketed
Jan 16, 2024	FamotidineANDA 217605	Pharmazone	0	Marketed
Mar 14, 2024	FamotidineANDA 218461	Graviti Pharms	0	Marketed
May 28, 2024	FamotidineANDA 218003	Contract Pharmacal	0	Marketed
Aug 6, 2024	FamotidineANDA 217400	Msn	0	Marketed
Oct 16, 2024	FamotidineANDA 218344	Epic Pharma LLC	0	Marketed
Mar 25, 2025	FamotidineANDA 218631	Regcon Holdings	0	Marketed
Jun 2, 2025	FamotidineANDA 217982	Lannett Co Inc	0	Marketed
Jun 23, 2025	FamotidineANDA 219153	Bionpharma	0	Discontinued
Jul 9, 2025	FamotidineANDA 219091	Aurobindo Pharma Ltd	0	Marketed
Jul 16, 2025	FamotidineNDA 219935 · New formulation or manufacturer	Sagent	0	Discontinued
Jul 24, 2025	FamotidineANDA 219863	Msn	0	Marketed
Mar 9, 2026	FamotidineANDA 219603	Contract Pharmacal	0	Marketed
May 12, 2026	FamotidineANDA 217432	Lupin	0	Marketed
—	FamotidineANDA 75192	Marsam Pharms LLC	0	Discontinued
—	FamotidineANDA 75193	Marsam Pharms LLC	0	Discontinued
—	FamotidineANDA 75194	Marsam Pharms LLC	0	Discontinued
—	FamotidineANDA 75707	Apothecon	0	Discontinued
—	Famotidine Preservative FreeANDA 75708	Apothecon	0	Discontinued

Show all 103

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA