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001	PEPCID AC	FAMOTIDINE	TABLET, CHEWABLE;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N020801-001	PEPCID AC	FAMOTIDINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL		RLD	1998-09-24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N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`84e616aacf4f…`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N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`caaa826d4ba7…`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UTC	2026-02	N020801-001	PEPCID AC	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, CHEWABLE / ORAL	RLD	1998-09-24	`011fe1cb6892…`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 7 of 15 · 289 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Famotidine	FAMOTIDINE	Chain Drug Marketing Association INC	1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a	2025-07-17	Warnings	Name fallback generic name: FAMOTIDINE
equate famotidine	FAMOTIDINE	WALMART INC.	f38f8a8f-3292-4fe5-b83f-ffd634196d42	2025-07-16	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Little Pharma, Inc.	33dc93a5-ee03-2e68-e063-6294a90aeee1	2025-07-05	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Proficient Rx LP	702dd4fa-4a78-454d-91c5-493894750f7b	2025-07-01	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
acid controller	FAMOTIDINE	H E B	813d742f-8f3d-4f18-a6c5-03eea946f976	2025-06-23	Warnings	Name fallback generic name: FAMOTIDINE
TopCare Acid Reducer	FAMOTIDINE	Topco Associates LLC	88722f84-dac8-4130-93b3-9e0dc1cc5acc	2025-06-13	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	FAMILY DOLLAR	99698eea-6bf1-42e8-9f48-d58fc0437324	2025-06-06	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Dr.Reddys Laboratories Limited	387088a6-8eaa-fc49-8050-a546d0f0fd32	2025-06-03	Warnings	Name fallback generic name: FAMOTIDINE
Calmicid AC Acid Reducer	FAMOTIDINE	Melaleuca, Inc.	369ae213-cd23-57ba-e063-6394a90a87a6	2025-06-02	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Bi-Mart	140440fb-d420-490d-8d7d-4b01c8ed3a83	2025-06-01	Warnings	Name fallback generic name: FAMOTIDINE
FAMOTIDINE	FAMOTIDINE	Carnegie Pharmaceuticals LLC	45df5fae-b28a-4b48-95ef-96e4faad883f	2025-05-30	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Precision Dose, Inc.	de42b6c4-c44b-4ec1-b505-fc5266452d57	2025-05-27	Warnings	Name fallback generic name: FAMOTIDINE
Zantac 360	FAMOTIDINE	Chattem, Inc.	89f60eb1-359b-40e8-ae8b-65aec9cd5b1f	2025-05-09	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Lannett Company, Inc.	7e0da8be-b001-400e-99d1-37f335b1d7b3	2025-05-02	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Magno-Humphries, Inc.	f5d5b40e-82e5-4284-9f3f-d2c0e88f0ab9	2025-05-02	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Magno-Humphries, Inc.	ed32f72a-e220-440f-a74f-b754a313f004	2025-05-02	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	LEADER/ CARDINAL HEALTH 110, INC.	78b168f1-846d-4e88-a8ee-845c41c9dcbe	2025-04-23	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Bryant Ranch Prepack	11ce2a78-76ce-44df-afe3-57493498e596	2025-04-23	Warnings, Adverse reactions	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Better Living Brands, LLC	f6f0230c-44fb-6c36-e053-6394a90ac43e	2025-04-23	Warnings	Name fallback generic name: FAMOTIDINE
Famotidine	FAMOTIDINE	Fred's, Inc.	81b105a1-01fe-51d7-e053-2991aa0a71bc	2025-04-23	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
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