FDA.reportPublic FDA data

acid reducer

Product NDC
11822-0141
Requested package NDC
11822-0141-1
11-digit product format
118220141
Labeler code
11822
Product ID
11822-0141_ac9b167c-9705-471d-b127-153879ad3e26
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA075400
Marketing category
ANDA
Marketing start
2009-09-10
Marketing end
0000-00-00
Substance
FAMOTIDINE
Active strength
10 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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-014111822-0141-1DDiscontinued by firm2026-08-03

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075400-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2005-03-18

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-183f01610625f2…
2019-09-15 20:21 UTC2019-09A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075400-001FAMOTIDINE10MGTABLET / ORAL2005-03-18cb3db0bc1861…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8ACID REDUCER ORIGINAL STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]2
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8ACID REDUCER ORIGINAL STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZACID REDUCER ORIGINAL STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACID REDUCER ORIGINAL STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ACID REDUCER ORIGINAL STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTACID REDUCER ORIGINAL STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACID REDUCER ORIGINAL STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACID REDUCER ORIGINAL STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEACID REDUCER ORIGINAL STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AACID REDUCER ORIGINAL STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACID REDUCER ORIGINAL STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]2
TALCINACTIVE INGREDIENT7SEV7J4R1UACID REDUCER ORIGINAL STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACID REDUCER ORIGINAL STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ACID REDUCER ORIGINAL STRENGTH (FAMOTIDINE) TABLET [RITE AID CORPORATION]2

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareOne Acid ReliefFAMOTIDINEAmerican Sales Companyed474c9d-c08b-4f52-8b24-5887978e42752026-07-01WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
acid reliefFAMOTIDINERite Aid Corporation9826dd26-5592-4f96-9274-005ef9462cb42026-05-27WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
good sense acid reducerFAMOTIDINEL. Perrigo Companycc77f6ff-a534-4731-b971-4912808408992026-05-18WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
acid reducer original strengthFAMOTIDINEHyVee Inca0f2683f-59ad-4f65-a108-696430d577ab2026-03-16WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
Acid Controller Original StrengthFAMOTIDINEWalgreen Company98c6ddc9-8103-40b3-a145-ffbe3374ab6c2026-03-03WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
heartburn relief original strengthFAMOTIDINEMajor Pharmaceuticalsbe275c48-18bf-45f6-891d-36d89327813e2026-02-13WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
ACID CONTROLLERFAMOTIDINESafeway9ddfb9fd-1b84-4e9a-90b5-6a3362d345dd2025-08-13WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
acid controllerFAMOTIDINEH E B813d742f-8f3d-4f18-a6c5-03eea946f9762025-06-23WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
TopCare Acid ReducerFAMOTIDINETopco Associates LLC88722f84-dac8-4130-93b3-9e0dc1cc5acc2025-06-13WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
heartburn reliefFAMOTIDINEMeijer Distribution Inc05c03fd8-abc8-47f7-868c-895b9a38c5b32025-02-17WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
acid reducerFAMOTIDINEPublix Super Markets Inca3ba9983-6747-45b2-b270-4ac1fb9d6e402025-02-17WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
acid controller original strengthFAMOTIDINECVS Pharmacyc7cb4e19-3442-45d2-b60a-87d4beea862a2025-02-13WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
dg health heartburn prevention original strengthFAMOTIDINEDolgencorp, LLCf5c0ff75-77da-443c-a510-9c6a065ddc6c2025-02-11WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
foster and thrive acid reducerFAMOTIDINEStrategic Sourcing Services LLC9ff8539f-cdcd-4823-8baa-10a249c9220d2025-02-10WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
basic care acid reducerFAMOTIDINEAmazon.com Services LLC52e3b2f5-f3b9-4f4e-a70f-322eb04e6e8a2025-02-10WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
signature care acid controllerFAMOTIDINESafewayadbf2c58-cd1c-4444-b133-21a18a3489312025-02-10WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
equaline heartburn preventionFAMOTIDINEUnited Natural Foods, Inc. dba UNFI4b78d0c8-7d0c-45e6-9b36-b248f002f2b82025-02-10WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
Equate FamotidineFAMOTIDINEWal-Mart Stores Inc15973213-0e11-4d18-b437-50b0a593cb7b2025-02-06WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400
heartburn relief original strengthFAMOTIDINEProficient Rx LP5567aaaf-b4f2-4604-b841-c9447e77256c2019-10-01WarningsExact identifier
application applno (ANDA): 075400
application number: ANDA075400

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0141-1118220141012 BOTTLE in 1 CARTON (11822-0141-1) > 90 TABLET, FILM COATED in 1 BOTTLE2 bottle2009-09-100000-00-00NoNoCurrent