Application 020325

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;ORAL	10MG	Yes	No
002	PEPCID AC	FAMOTIDINE	TABLET;ORAL	20MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020325-001	PEPCID AC	FAMOTIDINE	10MG	TABLET / ORAL		RLD	1995-04-28
N020325-002	PEPCID AC	FAMOTIDINE	20MG	TABLET / ORAL		RLD, RS	2003-09-23

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020325-001	PEPCID AC	10MG	TABLET / ORAL	RLD	1995-04-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020325-002	PEPCID AC	20MG	TABLET / ORAL	RLD, RS	2003-09-23	`782e0a99824c…`

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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pepcid AC Original Strength	FAMOTIDINE	Kenvue Brands LLC	54f4086f-e443-4e7e-8c7e-94e152e1c256	2026-02-06	Warnings	Exact identifier application applno (NDA): 020325 application number: NDA020325 ndc (product): 16837-872
PEPCID AC Maximum Strength	FAMOTIDINE	Kenvue Brands LLC	2854047f-c5c4-43c3-8ef2-5c0a84a307f2	2024-11-11	Warnings	Exact identifier application applno (NDA): 020325 application number: NDA020325 ndc (product): 16837-855
Maximum Strength PEPCID AC Icy Cool Mint	FAMOTIDINE	Kenvue Brands LLC	0f343092-4fc7-1fff-e063-6294a90aba6e	2024-11-11	Warnings	Exact identifier application applno (NDA): 020325 application number: NDA020325
Pepcid AC	FAMOTIDINE	Lil' Drug Store Products, Inc.	14406cd8-468b-403d-9be2-43decd304214	2024-01-09	Warnings	Exact identifier application applno (NDA): 020325 application number: NDA020325 ndc (product): 66715-9748

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16837-855	PEPCID AC	Famotidine	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-855	PEPCID AC	Famotidine	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-855	PEPCID AC	Famotidine	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-855	PEPCID AC	Famotidine	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-855	PEPCID AC	Famotidine	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-855	PEPCID AC	Famotidine	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-855	PEPCID AC	Famotidine	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-855	PEPCID AC	Famotidine	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-855	PEPCID AC	Famotidine	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-872	Pepcid AC	Famotidine	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-872	Pepcid AC	Famotidine	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-872	Pepcid AC	Famotidine	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-872	Pepcid AC	Famotidine	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-872	Pepcid AC	Famotidine	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-872	Pepcid AC	Famotidine	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-872	Pepcid AC	Famotidine	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
16837-872	Pepcid AC	Famotidine	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	NDA	Current
66715-9748	Pepcid AC	Famotidine	Lil' Drug Store Products, Inc.	NDA	Current
66715-9748	Pepcid AC	Famotidine	Lil' Drug Store Products, Inc.	NDA	Current
66715-9748	Pepcid AC	Famotidine	Lil' Drug Store Products, Inc.	NDA	Current
66715-9748	Pepcid AC	Famotidine	Lil' Drug Store Products, Inc.	NDA	Current
66715-9748	Pepcid AC	Famotidine	Lil' Drug Store Products, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85046	SUPPL	2026-02-13
85015	SUPPL	2026-02-13
76853	SUPPL	2023-12-15
76851	SUPPL	2023-12-15
72961	SUPPL	2022-12-20
72914	SUPPL	2022-12-16
70235	SUPPL	2022-02-23
58443	SUPPL	2019-04-26
58286	SUPPL	2019-04-10
12444	SUPPL	2016-06-13
2332	SUPPL	2016-06-09
12443	SUPPL	2016-04-11
41279	SUPPL	2007-05-29
24776	SUPPL	2006-06-12
2331	SUPPL	2004-10-29
24775	SUPPL	2003-09-30
12442	SUPPL	2003-09-30
2330	SUPPL	2002-03-01
2329	SUPPL	2002-03-01