Application 019510

Type: NDA
Sponsor: MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEPCID	FAMOTIDINE	INJECTABLE;INJECTION	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	PEPCID PRESERVATIVE FREE	FAMOTIDINE	INJECTABLE;INJECTION	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
N019510-001	PEPCID	FAMOTIDINE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-11-04
N019510-004	PEPCID PRESERVATIVE FREE	FAMOTIDINE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-11-04

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	N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019510-001	PEPCID	10MG/ML	INJECTABLE / INJECTION	RLD	1986-11-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	RLD	1986-11-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019510-001	PEPCID	10MG/ML	INJECTABLE / INJECTION	RLD	1986-11-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	RLD	1986-11-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`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 9 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	CVS Pharmacy, Inc.	c4e1ef3d-7391-66f5-e053-2995a90abc00	2025-03-28	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Harris Teeter	bc548297-7646-4dbf-bfc5-65f2bc629676	2025-03-26	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Aurohealth LLC	27ecf5c1-202a-44cf-94f9-d7fefa027e1e	2025-03-15	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	WALGREEN CO.	316e3815-6ae1-47c3-8a75-fd57f8434a6f	2025-03-15	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Wal-Mart Stores, Inc.	018b02e8-1005-4736-a4fc-962881f52adf	2025-03-15	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Aurohealth LLC	756c7234-6a63-4b1b-be36-2b1ed09e67a0	2025-03-15	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Aurobindo Pharma Limited	b0798337-1a73-415e-8416-613984ce5c65	2025-03-04	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Golden State Medical Supply, Inc.	c72fad2e-3ffb-4f83-e053-2a95a90a3f9c	2025-02-18	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
heartburn relief	FAMOTIDINE	Meijer Distribution Inc	05c03fd8-abc8-47f7-868c-895b9a38c5b3	2025-02-17	Warnings	Name fallback generic name: FAMOTIDINE
acid reducer	FAMOTIDINE	Publix Super Markets Inc	a3ba9983-6747-45b2-b270-4ac1fb9d6e40	2025-02-17	Warnings	Name fallback generic name: FAMOTIDINE
acid controller original strength	FAMOTIDINE	CVS Pharmacy	c7cb4e19-3442-45d2-b60a-87d4beea862a	2025-02-13	Warnings	Name fallback generic name: FAMOTIDINE
heartburn relief	FAMOTIDINE	Meijer Distribution Inc	263ee489-fc3f-4578-b3a5-44f6d7757898	2025-02-13	Warnings	Name fallback generic name: FAMOTIDINE
kirkland signature acid controller	FAMOTIDINE	Costco Wholesale Company	d5d96078-ba87-4593-b15b-b7a646a8ab10	2025-02-12	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	LEADER/ Cardinal Health 110, Inc.	287525d8-83ef-7110-e063-6294a90ad373	2025-02-11	Warnings	Name fallback generic name: FAMOTIDINE
Acid Controller	FAMOTIDINE	H E B	cbe72270-b172-4662-9b9b-557e8cf53ffe	2025-02-11	Warnings	Name fallback generic name: FAMOTIDINE
dg health heartburn prevention original strength	FAMOTIDINE	Dolgencorp, LLC	f5c0ff75-77da-443c-a510-9c6a065ddc6c	2025-02-11	Warnings	Name fallback generic name: FAMOTIDINE
foster and thrive acid reducer	FAMOTIDINE	Strategic Sourcing Services LLC	9ff8539f-cdcd-4823-8baa-10a249c9220d	2025-02-10	Warnings	Name fallback generic name: FAMOTIDINE
basic care acid reducer	FAMOTIDINE	Amazon.com Services LLC	52e3b2f5-f3b9-4f4e-a70f-322eb04e6e8a	2025-02-10	Warnings	Name fallback generic name: FAMOTIDINE
signature care acid controller	FAMOTIDINE	Safeway	adbf2c58-cd1c-4444-b133-21a18a348931	2025-02-10	Warnings	Name fallback generic name: FAMOTIDINE
basic care acid reducer	FAMOTIDINE	Amazon.com Services LLC	0983cef7-b8b6-4ed9-a01e-c699fa6d2d06	2025-02-10	Warnings	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
20251	SUPPL	2009-01-12
17423	SUPPL	2007-11-08
33766	SUPPL	2007-11-07
33764	ORIG	2003-04-30
17422	SUPPL	2002-06-06
11516	SUPPL	2002-06-06
33765	SUPPL	2001-03-14
1352	SUPPL	2001-03-14
40915	SUPPL	1999-03-18