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N019462-001	PEPCID	FAMOTIDINE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15
N019462-002	PEPCID	FAMOTIDINE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15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N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`caaa826d4ba7…`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 4 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equate Famotidine	FAMOTIDINE	Wal-Mart Stores Inc	8ac94821-aa78-4e57-bc9a-f1f2a0e47b07	2026-03-03	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Proficient Rx LP	d60bde93-f512-4071-9e4b-1d8318def3bc	2026-03-01	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
acid controller	FAMOTIDINE	Walgreen Company	c16d9977-39ad-4386-8867-72aab97c99d5	2026-02-28	Warnings	Name fallback generic name: FAMOTIDINE
berkley and jensen famotidine	FAMOTIDINE	BJWC	93c857e4-72b3-433e-ae6f-281cd57e3996	2026-02-17	Warnings	Name fallback generic name: FAMOTIDINE
heartburn relief original strength	FAMOTIDINE	Major Pharmaceuticals	be275c48-18bf-45f6-891d-36d89327813e	2026-02-13	Warnings	Name fallback generic name: FAMOTIDINE
Pepcid AC Original Strength	FAMOTIDINE	Kenvue Brands LLC	54f4086f-e443-4e7e-8c7e-94e152e1c256	2026-02-06	Warnings	Name fallback generic name: FAMOTIDINE
acid reducer	FAMOTIDINE	H E B	140f0e60-c809-4d86-a750-7649ee2881b5	2026-02-03	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	GLENMARK THERAPEUTICS INC., USA	95f51f27-d367-4cfd-a15f-7856c9e361fb	2026-01-13	Warnings	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Aurobindo Pharma Limited	18066b80-1ec6-4092-80d9-70adb0ecac85	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Bryant Ranch Prepack	900b4fd6-9c62-4b64-b4db-760c49ae0a42	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Alembic Pharmaceuticals Inc.	f149ecc1-d66c-42f9-a3f4-2ab6a522942b	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
acid relief	FAMOTIDINE	Rite Aid Corporation	45789b7a-e9c7-4813-b07b-f88d9108455d	2026-01-06	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Northwind Health Company, LLC	f2b6da72-72ea-d81b-e053-2995a90a9526	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Northwind Health Company, LLC	ab1cdbbf-d838-020c-e053-2995a90a0f65	2026-01-01	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	A-S Medication Solutions	74a69baa-a7c5-4e67-8db6-2ec39ab6cfe5	2025-12-30	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Northwind Health Company, LLC	43454e0f-4e1e-bbc6-e063-6394a90a5ac4	2025-12-29	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Lupin Pharmaceuticals, Inc.	2caaf94b-b382-4573-8614-57815776b659	2025-12-29	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Northwind Health Company, LLC	03503cd5-bd8e-4bff-b90d-1a71c5225b91	2025-12-26	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Redpharm Drug	37361ccf-e080-d58e-e063-6394a90ab92e	2025-12-24	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	SAFEWAY	f18c1195-48a1-69dc-e053-2a95a90a4077	2025-12-18	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