Famotidine

Product NDC
63868-486
11-digit product format
638680486
Labeler code
63868
Product ID
63868-486_096b7006-c1ab-4b96-b482-b7914ef518e7
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chain Drug Marketing Association Inc.
Application
ANDA090283
Marketing category
ANDA
Marketing start
2010-07-23
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63868-486IInactivated by FDA2026-08-03
excluded packagepackage63868-48663868-486-25IInactivated by FDA2026-08-03
excluded packagepackage63868-48663868-486-50IInactivated 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 · 63 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 packagepackage63868-486-25d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63868-486-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63868-486-25f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63868-486-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63868-486-252ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63868-486-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63868-486-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63868-486-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63868-486-25cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63868-486-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63868-486-25cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63868-486-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63868-486-25302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63868-486-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63868-486-25ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63868-486-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63868-486-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63868-486-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63868-486-25ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63868-486-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63868-486-25367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63868-486-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63868-486-25557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63868-486-50557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63868-486-258af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage63868-486-508af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63868-486-25834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63868-486-50834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63868-486-251332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63868-486-501332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage63868-486-25fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage63868-486-50fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63868-486-2586f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage63868-486-5086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63868-486-25bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage63868-486-50bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63868-486-258dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63868-486-508dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63868-486-25e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63868-486-50e2bbac7714bc…27bdfed8d636…

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
63868-486-252020-01-31C16284748780-19d75b9d0-8eed-f424-e053-dadaa90a57ceDrug Facts
63868-486-502020-01-31C16284748780-19d75b9d0-8eed-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-486-25Famotidine25 in 1 BOTTLETABLET, FILM COATED253
63868-486-50Famotidine50 in 1 BOTTLETABLET, FILM COATED503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-486-25EA - Each63868-486d46626f0-4a55-4786-b0c9-9a3a0461a36212013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-486FAMOTIDINE TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]3Legacy NDC, 2 package rows20180824_1e6cebc6-a79a-405e-9824-197534a8b08b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199047famotidine 10 MG Oral TabletPSN1e6cebc6-a79a-405e-9824-197534a8b08b3
310273famotidine 20 MG Oral TabletPSN1e6cebc6-a79a-405e-9824-197534a8b08b3
199047famotidine 10 MG Oral TabletSCD1e6cebc6-a79a-405e-9824-197534a8b08b3
310273famotidine 20 MG Oral TabletSCD1e6cebc6-a79a-405e-9824-197534a8b08b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63868-486-256386804862525 in 1 BOTTLEHistorical
63868-486-506386804865050 in 1 BOTTLEHistorical