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 44.

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N019462-001	PEPCID	FAMOTIDINE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15
N019462-002	PEPCID	FAMOTIDINE	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15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 2 of 3 · 88 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
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…`
2022-03-09 01:35 UTC	2022-03	N019462-001	PEPCID	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019462-002	PEPCID	40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019462-001	PEPCID	20MG	TABLET / ORAL		RLD	1986-10-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N019462-002	PEPCID	40MG	TABLET / ORAL		RLD	1986-10-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019462-001	PEPCID	20MG	TABLET / ORAL		RLD	1986-10-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019462-002	PEPCID	40MG	TABLET / ORAL		RLD	1986-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019462-001	PEPCID	20MG	TABLET / ORAL		RLD	1986-10-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N019462-002	PEPCID	40MG	TABLET / ORAL		RLD	1986-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019462-001	PEPCID	20MG	TABLET / ORAL		RLD	1986-10-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N019462-002	PEPCID	40MG	TABLET / ORAL		RLD	1986-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019462-001	PEPCID	20MG	TABLET / ORAL		RLD	1986-10-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N019462-002	PEPCID	40MG	TABLET / ORAL		RLD	1986-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019462-001	PEPCID	20MG	TABLET / ORAL	AB	RLD	1986-10-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N019462-002	PEPCID	40MG	TABLET / ORAL	AB	RLD, RS	1986-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019462-001	PEPCID	20MG	TABLET / ORAL	AB	RLD	1986-10-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019462-002	PEPCID	40MG	TABLET / ORAL	AB	RLD, RS	1986-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019462-001	PEPCID	20MG	TABLET / ORAL	AB	RLD	1986-10-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019462-002	PEPCID	40MG	TABLET / ORAL	AB	RLD, RS	1986-10-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	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	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	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	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	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	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	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	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	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	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	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	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	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	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	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	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	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	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	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	`3a93d1ddd44b…`

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 1 of 15 · 284 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	REMEDYREPACK INC.	669fbd46-cae5-4477-884e-8eca893d2e05	2026-09-09	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Aurohealth LLC	5b161f25-c578-4ff4-a931-ff3a1e681c50	2026-09-04	Warnings	Name fallback generic name: FAMOTIDINE
ACID REDUCER	FAMOTIDINE	Amazon.com Services LLC	d5823283-aa97-451e-ba0d-69f0e79c8514	2026-08-31	Warnings	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	REMEDYREPACK INC.	9c5dce17-1865-4aa6-89f6-24dd55b5f06c	2026-08-27	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	599642c8-51cd-4220-e063-6394a90a5e20	2026-08-24	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Major Pharmaceuticals	3e6d167f-91e4-4122-911d-d3da66386f44	2026-08-20	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Preferred Pharmaceuticals Inc.	cd95271c-cf39-47fb-97a6-f6ee1e619e4a	2026-08-12	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
heartburn prevention	FAMOTIDINE	Kroger Company	c97851ef-7b49-4f6c-b165-147555db101a	2026-08-11	Warnings	Name fallback generic name: FAMOTIDINE
ACID REDUCER	FAMOTIDINE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f347f870-1da4-4a77-8c20-63b703d24071	2026-08-05	Warnings	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	PD-Rx Pharmaceuticals, Inc.	a0f38398-4d34-4ecc-8a6a-37732adaaad3	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Ascend Laboratories, LLC	b2228be0-472b-4e47-9910-af0bf12fde77	2026-07-27	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	HAWAII REPACK, INC.	eec89230-47fc-4139-a370-b4f9e225e8c0	2026-07-13	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Advanced Rx of Tennessee, LLC	5648ca13-1add-56ec-e063-6294a90a6f29	2026-07-10	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
CareOne Acid Relief	FAMOTIDINE	American Sales Company	ed474c9d-c08b-4f52-8b24-5887978e4275	2026-07-01	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Redpharm Drug	55730918-d9e8-eaad-e063-6394a90aeda2	2026-06-30	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Zantac 360	FAMOTIDINE	Select Consumer Group LLC	529cef2d-e6cc-3b37-e063-6294a90aff59	2026-06-27	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Sportpharm LLC	4421ceb7-a114-436c-871a-7bc5444f8154	2026-06-26	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	RISING PHARMA HOLDINGS, INC.	c013654e-9cad-4c59-8fea-b00ae1567c18	2026-06-24	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	CVS Pharmacy, Inc.	7357f67e-0fc6-4555-aa8b-1df09cba9feb	2026-06-24	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Family Dollar Stores, LLC	4dc7c2c4-83c7-608d-e063-6294a90a90eb	2026-06-23	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