FAMOTIDINE

Product NDC
64679-972
11-digit product format
646790972
Labeler code
64679
Product ID
64679-972_28e963b7-6088-45ba-b030-8cb6cfcd84f0
Type
HUMAN OTC DRUG
Nonproprietary name
famotidine
Dosage form
TABLET
Route
ORAL
Labeler
Wockhardt USA LLC.
Application
ANDA077146
Marketing category
ANDA
Marketing start
2005-03-07
Marketing end
0000-00-00
Substance
FAMOTIDINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64679-972DDiscontinued by firm2026-09-14
excluded packagepackage64679-97264679-972-00DDiscontinued by firm2026-09-14
excluded packagepackage64679-97264679-972-01DDiscontinued by firm2026-09-14
excluded packagepackage64679-97264679-972-02DDiscontinued by firm2026-09-14
excluded packagepackage64679-97264679-972-03DDiscontinued by firm2026-09-14

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 2 · 80 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-972-02DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-972-03DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-972-00DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-972-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-972-02DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-972-03DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-972-00DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-972-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-972-02DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-972-03DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-972-00DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-972-01DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-972-02DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-972-03DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-972-00DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-972-01DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-972-02DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-972-03DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-972-00DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-972-01DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-972-02DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-972-03DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-972-00DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-972-01DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-972-02DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-972-03DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-972-00DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-972-01DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64679-972-02DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64679-972-03DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64679-972-00DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64679-972-01DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64679-972-02DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64679-972-03DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64679-972-00DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64679-972-01DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64679-972-02IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64679-972-00IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64679-972-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64679-972-03IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64679-972-02IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64679-972-00IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64679-972-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64679-972-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64679-972-02IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64679-972-00IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64679-972-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64679-972-03IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…

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.

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET [WOCKHARDT USA LLC.]1
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET [WOCKHARDT USA LLC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET [WOCKHARDT USA LLC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FAMOTIDINE TABLET [WOCKHARDT USA LLC.]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14FAMOTIDINE TABLET [WOCKHARDT USA LLC.]1
HYPROMELLOSE 2910 (6 CPS)INACTIVE INGREDIENT0WZ8WG20P6FAMOTIDINE TABLET [WOCKHARDT USA LLC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET [WOCKHARDT USA LLC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFAMOTIDINE TABLET [WOCKHARDT USA LLC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET [WOCKHARDT USA LLC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET [WOCKHARDT USA LLC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET [WOCKHARDT USA LLC.]1
WATERINACTIVE INGREDIENT059QF0KO0RFAMOTIDINE TABLET [WOCKHARDT USA LLC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64679-972-006467909720050000 TABLET in 1 DRUM (64679-972-00) 50000 tablet2005-03-070000-00-00NoNoCurrent
64679-972-0164679097201100 TABLET in 1 BOTTLE (64679-972-01) 100 tablet2005-03-070000-00-00NoNoCurrent
64679-972-026467909720210 BLISTER PACK in 1 CARTON (64679-972-02) > 10 TABLET in 1 BLISTER PACK10 blister pack2005-03-070000-00-00NoNoCurrent
64679-972-036467909720340000 TABLET in 1 DRUM (64679-972-03) 40000 tablet2005-03-070000-00-00NoNoCurrent