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 14 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
famotidine	FAMOTIDINE	Camber Consumer Care Inc	ebe3ca30-df25-4c56-8935-414a3431b5b9	2022-10-11	Warnings	Name fallback generic name: FAMOTIDINE
topcare acid reducer	FAMOTIDINE	Topco Associates LLC	7824fdab-cdd5-457d-9b14-b82b19ea9529	2022-10-03	Warnings	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	HF Acquisition Co LLC, DBA HealthFirst	9948991d-9405-c7c8-e053-2995a90a60ca	2022-10-01	Adverse reactions	Name fallback generic name: FAMOTIDINE
famotidine	FAMOTIDINE	Navinta LLC	0f34a3be-7554-4040-b808-5ba8bf064abc	2022-09-17	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Proficient Rx LP	f32d0929-de22-4bec-9e24-bb549cf2679f	2022-09-01	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Zantac 360 2 per blister 6 blisters	FAMOTIDINE	JC World Bell Wholesale Co., Inc.	fd61a2d6-5c8a-4e7a-8b19-37406b90f778	2022-08-15	Warnings	Name fallback generic name: FAMOTIDINE
dg health acid reducer	FAMOTIDINE	Dolgencorp Inc	3ffa405e-bc85-4614-afd0-7a8dfc288dad	2022-07-13	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Proficient Rx LP	c84b0ba3-1ba8-4da9-b5b8-186e01cda999	2022-07-01	Adverse reactions	Name fallback generic name: FAMOTIDINE
dg health heartburn prevention	FAMOTIDINE	Dolgencorp Inc	a8383769-ce8b-43eb-b1a6-5d73e7fcf30d	2022-06-07	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Mylan Institutional LLC	e3b13e23-122b-4bd4-95cf-b5a14b7afc05	2022-06-01	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Proficient Rx LP	68120de1-fd9a-4f93-b218-d99ed7c5080a	2022-06-01	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Proficient Rx LP	9baf2596-b771-4bae-a03c-d3af6716821d	2022-05-02	Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Proficient Rx LP	787724dc-0b4b-4973-852e-c7d722f637b0	2022-05-01	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Akorn	354a5a02-45cb-4ab0-88ee-6635d5a43b01	2022-03-10	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Ascent Pharmaceuticals, Inc.	b481dd30-7d64-43ec-85d4-2289db62cad7	2022-02-14	Warnings	Name fallback generic name: FAMOTIDINE
basic care acid reducer	FAMOTIDINE	Amazon.com Services LLC	94fbcebe-7d75-47c1-9eca-cfa9b952a3d5	2022-01-06	Warnings	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	XLCare Pharmaceuticals, Inc.	7b550cf9-221f-4f28-ba99-414ad7d5612f	2021-12-10	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Camber Pharmaceuticals, Inc.	902b5d4b-1707-4312-9f46-ef5ab86b00f0	2021-11-19	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Amneal Pharmaceuticals NY LLC	bb602b05-0ce6-4029-bd6e-291076e64efb	2021-08-30	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Fresenius Kabi USA, LLC	ce533636-cc9b-45d0-87a6-5390377ff28a	2021-07-15	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