Application 020752

Type: NDA
Sponsor: MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEPCID RPD	FAMOTIDINE	TABLET, ORALLY DISINTEGRATING;ORAL	20MG	No	No
002	PEPCID RPD	FAMOTIDINE	TABLET, ORALLY DISINTEGRATING;ORAL	40MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020752-001	PEPCID RPD	FAMOTIDINE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-05-28
N020752-002	PEPCID RPD	FAMOTIDINE	40MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-05-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	1998-05-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	1998-05-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	1998-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	1998-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020752-001	PEPCID RPD	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020752-002	PEPCID RPD	40MG	TABLET, ORALLY DISINTEGRATING / ORAL		1998-05-28	`74a2ff9319b5…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 10 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equaline heartburn prevention	FAMOTIDINE	United Natural Foods, Inc. dba UNFI	4b78d0c8-7d0c-45e6-9b36-b248f002f2b8	2025-02-10	Warnings	Name fallback generic name: FAMOTIDINE
Major Heartburn Relief Maximum Strength	FAMOTIDINE	Major Pharmaceuticals	ee0a263e-3f78-4534-9a30-803de636f92b	2025-02-06	Warnings	Name fallback generic name: FAMOTIDINE
Equate Famotidine	FAMOTIDINE	Wal-Mart Stores Inc	15973213-0e11-4d18-b437-50b0a593cb7b	2025-02-06	Warnings	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	NuCare Pharmceuticals,Inc.	fc603d56-6828-8c5e-e053-6394a90a35bd	2025-02-05	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	NuCare Pharmaceuticals,Inc.	0786d7f5-85a7-d835-e063-6394a90ad719	2025-02-03	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Proficient Rx LP	c7327748-835b-44df-848f-8c620d327ce6	2025-02-01	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	NCS HealthCare of KY, LLC dba Vangard Labs	59b17677-d805-4d9e-9c64-96385ae47bff	2025-01-27	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	direct rx	b1b82d2a-cdb5-3e22-e053-2995a90a917d	2025-01-17	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	direct rx	c3de241e-6217-d6e0-e053-2a95a90a35c5	2025-01-17	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	AvPAK	dfdca61d-8824-6230-e053-2995a90a209d	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Advanced Rx Pharmacy of Tennessee, LLC	fa18ed52-f038-02dd-e053-6394a90ac946	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Quality Care Products, LLC	3549386a-533d-4e44-8097-f6bc51ee494a	2024-12-19	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Sagent Pharmaceuticals	2c4fe4e4-9ef2-4bc9-9016-e30ed9a5c958	2024-12-06	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Geri-Care Pharmaceutical Corp	288a8f87-e84a-a77a-e063-6294a90a86db	2024-12-05	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	GERI-CARE PHARMACEUTICAL CORP	287601b0-04ba-9611-e063-6394a90a9180	2024-12-04	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Zydus Lifesciences Limited	8c17f9e3-9827-4bf9-85ca-72e08a8518ca	2024-11-30		Name fallback generic name: FAMOTIDINE
PEPCID AC Maximum Strength	FAMOTIDINE	Kenvue Brands LLC	2854047f-c5c4-43c3-8ef2-5c0a84a307f2	2024-11-11	Warnings	Name fallback generic name: FAMOTIDINE
Maximum Strength PEPCID AC Icy Cool Mint	FAMOTIDINE	Kenvue Brands LLC	0f343092-4fc7-1fff-e063-6294a90aba6e	2024-11-11	Warnings	Name fallback generic name: FAMOTIDINE
dg health heartburn prevention	FAMOTIDINE	Dolgencorp Inc	679cdecb-9e25-4f43-b4f4-7f5f3fbf2296	2024-11-11	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Upsher-Smith Laboratories, LLC	d528fadf-316f-4fea-9bec-070c01f80d64	2024-11-08	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
20899	SUPPL	2007-07-09
20898	ORIG	2005-06-23
35272	SUPPL	2002-06-06
25699	SUPPL	2002-06-06
41644	SUPPL	1999-03-18
35271	ORIG	1998-05-28
3261	ORIG	1998-05-28