Application 019462

Type: NDA
Sponsor: VALEANT PHARMS NORTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEPCID	FAMOTIDINE	TABLET;ORAL	20MG	Yes	No
002	PEPCID	FAMOTIDINE	TABLET;ORAL	40MG	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
N019462-001	PEPCID	FAMOTIDINE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15
N019462-002	PEPCID	FAMOTIDINE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019462-001	PEPCID	20MG	TABLET / ORAL		RLD	1986-10-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019462-002	PEPCID	40MG	TABLET / ORAL		RLD	1986-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019462-001	PEPCID	20MG	TABLET / ORAL		RLD	1986-10-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019462-002	PEPCID	40MG	TABLET / ORAL		RLD	1986-10-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019462-001	PEPCID	20MG	TABLET / ORAL	AB	RLD	1986-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019462-002	PEPCID	40MG	TABLET / ORAL	AB	RLD, RS	1986-10-15	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019462-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019462-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N019462-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019462-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019462-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019462-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019462-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019462-002	AB	1	`ea99ee380514…`

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 6 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Preferred Pharmaceuticals Inc.	5ed77259-5dd9-4634-a073-346693488c4f	2025-09-23	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Preferred Pharmaceuticals Inc.	6edbd842-cf86-48a5-bc22-967620a2b5cb	2025-09-05	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
basic care heartburn prevention	FAMOTIDINE	Amazon.com Services LLC	8d57f6db-a9f0-4416-9f49-17ce3571b0aa	2025-09-04	Warnings	Name fallback generic name: FAMOTIDINE
careone acid relief	FAMOTIDINE	Retail Business Services, LLC	2f0f90cf-8f9a-4102-aab6-941aa0d35e4f	2025-08-26	Warnings	Name fallback generic name: FAMOTIDINE
maximum strength	FAMOTIDINE	Publix Super Markets Inc	f692ed61-d09a-484e-bf07-8afcedfb3208	2025-08-21	Warnings	Name fallback generic name: FAMOTIDINE
Leader Acid Reducer	FAMOTIDINE	Cardinal Health 110, LLC. dba Leader	321b83f9-4bbf-494a-9279-80b0742049b6	2025-08-21	Warnings	Name fallback generic name: FAMOTIDINE
foster and thrive acid reducer	FAMOTIDINE	Strategic Sourcing Services LLC	0c480ba4-b07e-4109-a9a9-5480b4a39a1d	2025-08-21	Warnings	Name fallback generic name: FAMOTIDINE
members mark acid pep	FAMOTIDINE	Sam's West Inc	f9f4a91c-60a2-4893-88e6-639d24237375	2025-08-21	Warnings	Name fallback generic name: FAMOTIDINE
TopCare Acid Reducer	FAMOTIDINE	Topco Associates LLC	c3c9ae86-f6d7-4a6c-a991-be8ef7c6adbe	2025-08-15	Warnings	Name fallback generic name: FAMOTIDINE
Rugby Famotidine	FAMOTIDINE	Rugby Laboratories	cdb6caa5-5be6-4597-a930-b8c816ac3040	2025-08-13	Warnings	Name fallback generic name: FAMOTIDINE
ACID CONTROLLER	FAMOTIDINE	Safeway	9ddfb9fd-1b84-4e9a-90b5-6a3362d345dd	2025-08-13	Warnings	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Ascend Laboratories, LLC	be69d9f9-f4ad-4cfe-bab2-e07186b25c1e	2025-08-07	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
acid controller	FAMOTIDINE	Safeway	f3d08f06-a676-43b0-8f77-611f0af737a7	2025-08-07	Warnings	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Micro Labs Limited	1756ab7d-05c4-4726-8f72-4e8363440968	2025-07-29	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Chain Drug Marketing Association INC	7fbc5e10-30c6-7f8d-1040-d48a80fe4d79	2025-07-22	Warnings	Name fallback generic name: FAMOTIDINE
Acid Reducer Original Strength	FAMOTIDINE	Dr.Reddys Laboratories Inc.	ca039876-f7e5-3e60-da5a-a1f40637a417	2025-07-17	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Albertsons Companies	27314f55-5e31-703c-b98c-ec89bf308472	2025-07-17	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Family Dollar Stores, Inc.	0f81e8ac-ddad-13d6-e883-6a5310e058de	2025-07-17	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Discount Drug Mart, Inc	c5d81352-c45b-3ea1-9974-8a096bd05009	2025-07-17	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Chain Drug Consortium, LLC	937f7bce-955b-9418-5aed-2e84aee50de3	2025-07-17	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
56427	SUPPL	2018-11-23
56447	SUPPL	2018-11-15
54697	SUPPL	2018-06-27
54662	SUPPL	2018-06-21
17411	SUPPL	2014-02-10
33754	SUPPL	2014-02-06
33753	SUPPL	2011-06-07
1333	SUPPL	2011-06-03
33752	SUPPL	2010-03-26
1332	SUPPL	2010-03-25
17410	SUPPL	2007-11-08
11510	SUPPL	2007-11-07
20246	SUPPL	2007-07-09
11508	ORIG	2003-04-30
33751	SUPPL	2003-04-24
17409	SUPPL	2002-06-06
11509	SUPPL	2002-06-06
1331	SUPPL	2001-03-14
20245	SUPPL	1999-03-18
57456	ORIG	1986-10-15