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 15 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Aphena Pharma Solutions - Tennessee, LLC	46c6d243-eefc-40ca-8bd4-4c89456f635f	2021-05-18	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	BluePoint Laboratories	8c7ca3cc-ff90-42a7-9218-554cf15348a3	2021-04-13	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Dr.Reddy's Laboratories Limited	06d286ce-14b3-4b66-8b42-ac4a10a0fc90	2020-11-17	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Aphena Pharma Solutions - Tennessee, LLC	b1839d23-20f4-4651-a7d2-8bc3a7583917	2020-07-06	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Proficient Rx LP	1e2003d4-09a3-4cc8-af3d-93d29b9123c0	2020-07-01	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Proficient Rx LP	92048836-e692-4ce1-93f4-88b00acabcde	2019-11-01	Adverse reactions	Name fallback generic name: FAMOTIDINE
heartburn relief original strength	FAMOTIDINE	Proficient Rx LP	5567aaaf-b4f2-4604-b841-c9447e77256c	2019-10-01	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Teva Pharmaceuticals USA, Inc.	4c6f4f9e-f3f5-4ecf-9f40-887e037e8847	2019-01-01	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Lupin Pharmaceuticals,Inc.	a0bdf4d1-8458-4e4f-95aa-bcc38c0f32f8	2017-11-21	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