acid reducer

Product NDC: 11822-0194
Requested package NDC: 11822-0194-5
11-digit product format: 118220194
Labeler code: 11822
Product ID: 11822-0194_b032833a-1133-49cf-b798-0995217541eb
Type: HUMAN OTC DRUG
Nonproprietary name: Famotidine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rite Aid Corporation
Application: ANDA077351
Marketing category: ANDA
Marketing start: 2006-09-29
Marketing end: 0000-00-00
Substance: FAMOTIDINE
Active strength: 20 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	11822-0194	11822-0194-5	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077351-001	FAMOTIDINE	FAMOTIDINE	20MG	TABLET / ORAL			2006-09-25

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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077351-001	FAMOTIDINE	20MG	TABLET / ORAL	2006-09-25	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FAMOTIDINE	ACTIVE INGREDIENT	5QZO15J2Z8	ACID REDUCER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]	3
FAMOTIDINE	ACTIVE MOIETY	5QZO15J2Z8	ACID REDUCER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	ACID REDUCER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACID REDUCER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ACID REDUCER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ACID REDUCER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACID REDUCER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ACID REDUCER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]	3
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	ACID REDUCER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACID REDUCER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ACID REDUCER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACID REDUCER MAXIMUM STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]	3

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 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Signature Care Acid Controller maximum strength	FAMOTIDINE	Safeway	ca5edcf8-1ed2-403a-a01b-0deb692bee0c	2026-06-30	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
acid relief	FAMOTIDINE	Rite Aid Corporation	8c6d5419-088b-4b3e-80b8-2a0d06926ff1	2026-06-03	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
ACID REDUCER	FAMOTIDINE	HyVee Inc	381db08e-5756-4255-8202-1d8e6a1cf038	2026-06-03	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
acid relief	FAMOTIDINE	Rite Aid Corporation	34034d16-dc3b-436d-8ec8-84b3c1f8e48a	2026-06-03	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
CareOne Acid Relief	FAMOTIDINE	American Sales Company	206f5483-7de1-4bc3-af27-190e211bcb95	2026-05-21	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
ACID REDUCER	FAMOTIDINE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f347f870-1da4-4a77-8c20-63b703d24071	2026-05-13	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
Good Sense Acid Reducer	FAMOTIDINE	L. Perrigo Company	39cb0f15-d177-46eb-a549-7acb885fbf07	2026-05-11	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
Acid Controller	FAMOTIDINE	Walgreen Company	42392cb1-7958-4a2f-8622-f00f02afd961	2026-04-24	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
acid controller	FAMOTIDINE	CVS Pharmacy	1531aa51-02e9-45ed-99aa-53b21732dd2e	2026-04-06	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
Rolaids ACID DEFENSE	FAMOTITINE	The Procter & Gamble Manufacturing Company	3bdbeabb-6b06-5468-e063-6394a90a03c9	2026-03-30	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
ACID REDUCER	FAMOTIDINE	Publix Super Markets Inc	3455be3c-696e-402a-a5df-830544fa525a	2026-03-11	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
Equate Famotidine	FAMOTIDINE	Wal-Mart Stores Inc	8ac94821-aa78-4e57-bc9a-f1f2a0e47b07	2026-03-03	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
acid controller	FAMOTIDINE	Walgreen Company	c16d9977-39ad-4386-8867-72aab97c99d5	2026-02-28	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
berkley and jensen famotidine	FAMOTIDINE	BJWC	93c857e4-72b3-433e-ae6f-281cd57e3996	2026-02-17	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
acid reducer	FAMOTIDINE	H E B	140f0e60-c809-4d86-a750-7649ee2881b5	2026-02-03	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
acid relief	FAMOTIDINE	Rite Aid Corporation	45789b7a-e9c7-4813-b07b-f88d9108455d	2026-01-06	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
careone acid relief	FAMOTIDINE	Retail Business Services, LLC	8f654234-b25d-47d6-b1f8-f7f353569795	2025-10-30	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
Acid Controller	FAMOTIDINE	H E B	8aac5a0d-074b-4cf4-ab10-549e1ed09e2f	2025-10-30	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
equaline heartburn prevention	FAMOTIDINE	United Natural Foods, Inc. dba UNFI	f40f1dcf-249a-4ccb-bdfc-acff49dd4a15	2025-09-25	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351
basic care heartburn prevention	FAMOTIDINE	Amazon.com Services LLC	8d57f6db-a9f0-4416-9f49-17ce3571b0aa	2025-09-04	Warnings	Exact identifier application applno (ANDA): 077351 application number: ANDA077351

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5QZO15J2Z8	FAMOTIDINE	76824-35-6	FAMOTIDINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11822-0194-5	11822019405	25 BLISTER PACK in 1 CARTON (11822-0194-5) > 1 TABLET, FILM COATED in 1 BLISTER PACK	25 blister pack	2006-09-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rite Aid Corporation Acid Reducer Drug Facts	Rite Aid Corporation	2021-07-21	HUMAN OTC DRUG LABEL	7