Famotidine

Product NDC
70253-128
11-digit product format
702530128
Labeler code
70253
Product ID
70253-128_5af0651f-ab83-4792-b462-4793f4d0c643
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET
Route
ORAL
Labeler
OUR FAMILY (Nash Finch Company)
Application
ANDA077146
Marketing category
ANDA
Marketing start
2013-10-15
Marketing end
0000-00-00
Substance
FAMOTIDINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70253-128IInactivated by FDA2026-09-14
excluded packagepackage70253-12870253-128-90IInactivated by FDA2026-09-14

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70253-128-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70253-128-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70253-128-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70253-128-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70253-128-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70253-128-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70253-128-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70253-128-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70253-128-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70253-128-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70253-128-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70253-128-90557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70253-128-908af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70253-128-90834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70253-128-901332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage70253-128-90fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage70253-128-9086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage70253-128-90bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage70253-128-908dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage70253-128-90e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage70253-128-909bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077146-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2005-03-07

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-0784e616aacf4f…
2026-08-18 06:07:402026-07A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-073f01610625f2…
2019-09-15 20:21 UTC2019-09A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077146-001FAMOTIDINE10MGTABLET / ORAL2005-03-07f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
396bde5c-c78e-2f8b-ab1f-2ee6ba32bcaeProduct name720260317
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
cf645750-2e70-f6e1-c05a-a52847def5ddProduct name920250312
4fdc761c-585e-054b-8ebe-86130a26e4c1Product name220221205
fc2e1e31-353a-2c24-a4b4-fcf93bf7e38eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70253-128-902020-01-31C16284748780-19d75b9d0-846d-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70253-128-90Famotidine1 in 1 BOXTABLET11
70253-128-90Famotidine90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET [OUR FAMILY (NASH FINCH COMPANY)]1
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET [OUR FAMILY (NASH FINCH COMPANY)]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET [OUR FAMILY (NASH FINCH COMPANY)]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FAMOTIDINE TABLET [OUR FAMILY (NASH FINCH COMPANY)]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PFAMOTIDINE TABLET [OUR FAMILY (NASH FINCH COMPANY)]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFAMOTIDINE TABLET [OUR FAMILY (NASH FINCH COMPANY)]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET [OUR FAMILY (NASH FINCH COMPANY)]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFAMOTIDINE TABLET [OUR FAMILY (NASH FINCH COMPANY)]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET [OUR FAMILY (NASH FINCH COMPANY)]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET [OUR FAMILY (NASH FINCH COMPANY)]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET [OUR FAMILY (NASH FINCH COMPANY)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70253-128FAMOTIDINE TABLET [OUR FAMILY (NASH FINCH COMPANY)]1Legacy NDC, 2 package rows20131015_26114e0f-ab13-4433-94ea-6b332a34f158.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN26114e0f-ab13-4433-94ea-6b332a34f1581
199047famotidine 10 MG Oral TabletSCD26114e0f-ab13-4433-94ea-6b332a34f1581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
70253-128-90702530128901 in 1 BOXHistorical