Application 020801

Type: NDA
Sponsor: J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PEPCID AC	FAMOTIDINE	TABLET, CHEWABLE;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	PEPCID AC	FAMOTIDINE	TABLET, CHEWABLE;ORAL	20MG	Yes	Yes

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
N020801-001	PEPCID AC	FAMOTIDINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD	1998-09-24
N020801-002	PEPCID AC	FAMOTIDINE	20MG	TABLET, CHEWABLE / ORAL		RLD, RS	2007-12-17

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020801-001	PEPCID AC	10MG	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020801-001	PEPCID AC	10MG	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020801-002	PEPCID AC	20MG	TABLET, CHEWABLE / ORAL	RLD, RS	2007-12-17	`74a2ff9319b5…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020801-002	6814978*PED	2022-02-26	Pediatric extension	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020801-002	6814978*PED	2022-02-26	Pediatric extension	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020801-002	6814978*PED	2022-02-26	Pediatric extension	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020801-002	6814978	2021-08-26	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020801-002	6814978*PED	2022-02-26	Pediatric extension	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020801-002	6814978*PED	2022-02-26	Pediatric extension	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020801-002	6814978	2021-08-26	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020801-002	6814978*PED	2022-02-26	Pediatric extension	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020801-002	6814978	2021-08-26	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020801-002	6814978*PED	2022-02-26	Pediatric extension	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020801-002	6814978	2021-08-26	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020801-002	6814978*PED	2022-02-26	Pediatric extension	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020801-002	6814978	2021-08-26	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020801-002	6814978*PED	2022-02-26	Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020801-002	6814978	2021-08-26	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020801-002	6814978*PED	2022-02-26	Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020801-002	6814978	2021-08-26	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020801-002	6814978*PED	2022-02-26	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020801-002	6814978	2021-08-26	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020801-002	6814978*PED	2022-02-26	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020801-002	6814978	2021-08-26	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020801-002	6814978*PED	2022-02-26	Pediatric extension	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N020801-002	6814978*PED	2022-02-26	Pediatric extension	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020801-002	6814978*PED	2022-02-26	Pediatric extension	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020801-002	6814978*PED	2022-02-26	Pediatric extension	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020801-002	6814978*PED	2022-02-26	Pediatric extension	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020801-002	6814978*PED	2022-02-26	Pediatric extension	`cb3db0bc1861…`

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
60711	SUPPL	2019-10-30
60710	SUPPL	2019-10-30
20968	SUPPL	2012-03-27
3393	SUPPL	2008-01-09
3392	SUPPL	2004-10-29
25869	SUPPL	2003-04-09
25870	SUPPL	2002-01-31
13462	SUPPL	2001-04-10
41710	ORIG	1998-09-24
25868	ORIG	1998-09-24
13461	ORIG	1998-09-24