Famotidine

Product NDC
51660-035
11-digit product format
516600035
Labeler code
51660
Product ID
51660-035_1030865a-0120-402c-b314-3cfce7ecc4e8
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
2010-02-15
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51660-035DDiscontinued by firm2026-08-03
excluded productproduct51660-035IInactivated by FDA2026-08-03
excluded packagepackage51660-03551660-035-31DDiscontinued by firm2026-08-03
excluded packagepackage51660-03551660-035-31IInactivated by FDA2026-08-03

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 2 · 66 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 productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51660-035-31IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51660-035-31DDiscontinued 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 productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51660-035-31IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51660-035-31DDiscontinued 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 productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51660-035-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51660-035-31DDiscontinued 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 productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51660-035-31IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51660-035-31DDiscontinued 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 productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51660-035-31IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51660-035-31DDiscontinued 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 productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51660-035-31IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51660-035-31DDiscontinued 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 productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51660-035-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51660-035-31DDiscontinued 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 productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51660-035-31IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51660-035-31DDiscontinued 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 productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51660-035-31IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51660-035-31DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51660-035-31IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51660-035-31DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51660-035-31IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51660-035-31DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51660-035-31IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51660-035-31DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51660-035-31IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51660-035-31IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51660-035-31IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51660-035-31IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51660-035-31IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51660-035-31IInactivated by FDAbd6a592717d7…303034d00443…

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…

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
51660-035-312020-01-31C16284748780-19d75b9d0-e7a6-f424-e053-dadaa90a57ceFamotidine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51660-035-31Famotidine30 in 1 BLISTER PACKTABLET, FILM COATED301
51660-035-31Famotidine1 in 1 CARTONTABLET, FILM COATED11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-035-31EA - Each51660-0353c117eb4-83f0-4562-93fe-5f3619ebb04112019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-035FAMOTIDINE TABLET, FILM COATED [OHM LABORATORIES INC. ]1Legacy NDC, 2 package rows20180910_9e951ab7-79ab-400f-adbf-739f801257c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN9e951ab7-79ab-400f-adbf-739f801257c91
199047famotidine 10 MG Oral TabletSCD9e951ab7-79ab-400f-adbf-739f801257c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51660-035-315166000353130 in 1 BLISTER PACKHistorical