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N019462-001	PEPCID	FAMOTIDINE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15
N019462-002	PEPCID	FAMOTIDINE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15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N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`caaa826d4ba7…`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 13 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pepcid AC	FAMOTIDINE	Lil' Drug Store Products, Inc.	14406cd8-468b-403d-9be2-43decd304214	2024-01-09	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	A-S Medication Solutions	d8cfa644-7cad-41b9-82a0-242a783fcbc8	2023-12-18	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	A-S Medication Solutions	2bde8e1d-078f-4ba1-9ccb-29de6e36d8c4	2023-12-18	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	A-S Medication Solutions	99de67a5-a566-46c9-bc80-dc6fc03be11f	2023-11-02	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	A-S Medication Solutions	ae3646c7-76fc-473d-b20b-67d3c6ac0b75	2023-10-25	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Zydus Pharmaceuticals USA Inc.	b165979b-7ed0-423e-9aeb-2e061df0cd45	2023-10-06	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	ANI Pharmaceuticals, Inc.	8e41e259-b161-4f11-a6f7-14e6b60885b8	2023-10-02	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	NorthStar Rx LLC	04aaf296-f136-29d7-e063-6294a90affe1	2023-09-07	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Ascend Laboratories, LLC	ea50552f-f9b9-467f-a925-62ff027df607	2023-08-25	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Camber Pharmaceuticals, Inc.	8e7f9c85-d165-47c7-8950-b22adcd6cece	2023-08-23	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	A-S Medication Solutions	74ff64f2-d882-411f-bac8-29dfa4cb4f10	2023-08-09	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Maximum Strength Acid Controller	FAMOTIDINE	BETTER LIVING BRANDS LLC.	f2c031b4-de86-3a8e-e053-2a95a90a21e0	2023-07-30	Warnings	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Biocon Pharma Inc.	ea7287a4-75e0-39d2-5b2e-b72b7cb386b9	2023-05-21	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Medical Purchasing Solutions, LLC	bbeffa0a-2bc7-fea4-e053-2a95a90ac511	2023-05-08	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Medical Purchasing Solutions, LLC	b6214fc9-a274-ef45-e053-2a95a90ae43a	2023-05-04	Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	BluePoint Laboratories	befd8d44-c6f7-eca2-e053-2995a90a714b	2023-03-23	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Proficient Rx LP	fe21daca-ac48-4b46-9cb3-9a69af0c6a84	2023-03-01	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Zydus Pharmaceuticals USA Inc.	a8010e10-68fd-455f-968f-d62a1c3e0ffd	2022-12-02	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Fresenius Kabi USA, LLC	aeb27cea-1ff7-4a6e-93f1-d4c4dac5faa7	2022-11-08	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Fresenius Kabi USA, LLC	5995d726-f3f8-4c2d-af19-1b12e3f769c6	2022-10-20	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
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