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001	PEPCID	FAMOTIDINE	INJECTABLE;INJECTION	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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FREE	FAMOTIDINE	INJECTABLE;INJECTION	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N019510-001	PEPCID	FAMOTIDINE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-11-04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PEPCID PRESERVATIVE FREE	FAMOTIDINE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1986-11-04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N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`84e616aacf4f…`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N019510-004	PEPCID PRESERVATIVE FREE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`84e616aacf4f…`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N019510-001	PEPCID	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1986-11-04	`caaa826d4ba7…`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 8 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.	c4e35c7e-5c2f-4252-e053-2a95a90a8268	2025-04-22	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	CVS Pharmacy, Inc.	479a1437-a212-49d9-b272-758c0e5b7203	2025-04-22	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Best Choice	fadbd056-6510-f864-e053-6294a90aa67b	2025-04-22	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Aurohealth LLC	f2b911c7-ce24-4d3d-8fb6-c34980191f40	2025-04-22	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Aurohealth LLC	6d0d8839-0680-45f6-96db-2d8edc9d4682	2025-04-22	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Wal-Mart Stores, Inc.	43fb44ea-07a1-4df9-8b4a-b2249757208e	2025-04-22	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Amerisource Bergen	d8df03ab-7c5c-4c8b-a3fb-6c6081e081e7	2025-04-22	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	WALGREEN CO.	2766ffe7-2f1c-48c8-8f67-0a2819dcc3be	2025-04-22	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	WALGREEN CO.	d0f74e78-7afb-49c2-e053-2a95a90a31dc	2025-04-22	Warnings	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Novadoz Pharmaceuticals LLC	21953598-e7ec-45c2-8fca-05550a1ddf38	2025-04-10	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
acid reducer	FAMOTIDINE	CVS Pharmacy	373f5e28-e9e2-4af7-8a27-29b5d8f28b50	2025-04-07	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Westminster Pharmaceuticals, LLC	c0e15f57-ab20-4030-b1d1-6aff33be7d76	2025-04-07	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	LEADER/ CARDINAL HEALTH 110, INC.	cdd509c4-331b-4aee-935c-dfc44d5943ed	2025-04-05	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	WALGREEN CO.	e9ded705-85c7-1380-e053-2995a90a68ec	2025-04-05	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Bi-Mart	9974aa5e-e03f-4459-934a-ece27a830746	2025-04-01	Warnings	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Bryant Ranch Prepack	a24e8f45-6ace-4a81-8005-c23a55dadd9a	2025-03-31	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Best Choice	fadb9d53-4cc6-83d6-e053-6394a90aa2e3	2025-03-28	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Amerisource Bergen	a5d88925-efca-4240-9eb5-6a9d0ac7a67e	2025-03-28	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Better Living Brands LLC	f6f07e25-2b31-b0c4-e053-6294a90a8ffb	2025-03-28	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	HARRIS TEETER, LLC	e49e087c-ee20-3174-e053-2995a90a1d09	2025-03-28	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