Famotidine - Acid Controller

Product NDC
51660-036
11-digit product format
516600036
Labeler code
51660
Product ID
51660-036_04ac9d5d-6606-4157-a71e-d5762d391ee8
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ohm Laboratories Inc.
Application
ANDA090283
Marketing category
ANDA
Marketing start
2017-05-31
Marketing end
0000-00-00
Substance
FAMOTIDINE
Active strength
20 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 productproduct51660-036DDiscontinued by firm2026-08-03
excluded packagepackage51660-03651660-036-26DDiscontinued 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 · 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 packagepackage51660-036-26d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51660-036-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51660-036-262ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51660-036-26a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51660-036-26cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51660-036-26cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51660-036-26302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51660-036-26ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51660-036-260efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51660-036-26ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51660-036-26367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51660-036-26557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51660-036-268af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51660-036-26834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51660-036-261332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51660-036-26fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51660-036-2686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51660-036-26bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51660-036-268dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51660-036-26e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51660-036-269bebd1f3094a…5416666fcb17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090283-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2009-11-17
A090283-002FAMOTIDINEFAMOTIDINE20MGTABLET / ORAL2009-11-17

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090283-001FAMOTIDINE10MGTABLET / ORAL2009-11-17782e0a99824c…
2021-12-28 21:50 UTC2021-12A090283-002FAMOTIDINE20MGTABLET / ORAL2009-11-17782e0a99824c…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51660-036-262020-01-31C16284748780-19d75b9d0-9acf-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-036-26EA - Each51660-036f37e497d-acc0-44c5-920d-3dec848d9e3512019-03-12
51660-036-50EA - Each51660-036ffb86c67-4b3c-414b-bb42-e707b886a67512019-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PFAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-036FAMOTIDINE - ACID CONTROLLER (FAMOTIDINE) TABLET, FILM COATED [OHM LABORATORIES INC.]6Legacy NDC20171116_653c165e-3e22-4796-b170-cc87547574c4.zip