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N019462-001	PEPCID	FAMOTIDINE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15
N019462-002	PEPCID	FAMOTIDINE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15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N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`caaa826d4ba7…`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 5 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Redpharm Drug	44f3f63d-4522-91e4-e063-6394a90a6d1b	2025-12-02	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Ajanta Pharma USA Inc.	a88e7069-230c-4105-ade0-a98968e18671	2025-11-30	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Novadoz Pharmaceuticals LLC	74a24590-a0b6-4607-8e67-9fadce53389b	2025-11-12	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	AvPAK	85c7d20d-3dec-b918-4c1d-8ca1db214e48	2025-11-11	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
famotidine	FAMOTIDINE	Chartwell RX, LLC	70714491-1368-4824-98af-03fda52139a9	2025-11-04	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Heartburn Relief	FAMOTIDINE	Shield Pharmaceuticals Corp	a12ec91d-244f-45c5-8590-d1e4485fe361	2025-10-31	Warnings	Name fallback generic name: FAMOTIDINE
careone acid relief	FAMOTIDINE	Retail Business Services, LLC	8f654234-b25d-47d6-b1f8-f7f353569795	2025-10-30	Warnings	Name fallback generic name: FAMOTIDINE
Acid Controller	FAMOTIDINE	H E B	8aac5a0d-074b-4cf4-ab10-549e1ed09e2f	2025-10-30	Warnings	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Bryant Ranch Prepack	7cef62ab-1740-4d0f-b6ea-fda783e1c197	2025-10-23	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	002875d2-8c30-2d2e-e063-6294a90ae01e	2025-10-22	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	66f0bf15-ff35-426a-b40c-0d0da79d0861	2025-10-16	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	09ef39a4-c6b3-4395-8211-3f551dc44830	2025-10-16	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	5798d282-ce83-49aa-bc33-13203f2b5285	2025-10-15	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	2f5ec69d-926c-47a2-be47-8fef2e0ff207	2025-10-14	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	c133a9e1-ca48-4ee2-8768-01f44f5dd511	2025-10-14	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	A-S Medication Solutions	3c32f8e2-f54a-422d-9c25-68692ea09001	2025-10-10	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	a3b50576-cd40-4f7e-9506-bd0a61988424	2025-10-09	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Zantac 360 Cool Mint	FAMOTIDINE	Chattem, Inc.	19fe7c6e-243c-4005-a63a-f8cac1ce55c8	2025-09-30	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	e034546b-28cb-41aa-9441-655cdb966554	2025-09-29	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
equaline heartburn prevention	FAMOTIDINE	United Natural Foods, Inc. dba UNFI	f40f1dcf-249a-4ccb-bdfc-acff49dd4a15	2025-09-25	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