Famotidine

Product NDC
0093-2748
Requested package NDC
0093-2748-94
11-digit product format
000932748
Labeler code
0093
Product ID
0093-2748_fdbd1f73-5aa9-46f6-ace8-2742dc8c490e
Type
HUMAN OTC DRUG
Nonproprietary name
Famotidine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA075512
Marketing category
ANDA
Marketing start
2015-01-08
Marketing end
2021-11-26
Substance
FAMOTIDINE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0093-27480093-2748-94DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075512-001FAMOTIDINEFAMOTIDINE10MGTABLET / ORAL2001-07-26

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-263f01610625f2…
2019-09-15 20:21 UTC2019-09A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075512-001FAMOTIDINE10MGTABLET / ORAL2001-07-26cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-2748-65EA - Each0093-2748025f922f-4d67-44df-8eaf-5a5af9779a2612015-01-05
0093-2748-92EA - Each0093-2748f5e88dd8-6b18-4cdf-9ae3-a9df6b1c907612015-01-05
0093-2748-94EA - Each0093-27482ed23ca7-cbb6-4672-836f-56d03e51b0bd12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FAMOTIDINEACTIVE INGREDIENT5QZO15J2Z8FAMOTIDINE TABLET [TEVA PHARMACEUTICALS USA INC]1
FAMOTIDINEACTIVE MOIETY5QZO15J2Z8FAMOTIDINE TABLET [TEVA PHARMACEUTICALS USA INC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933FAMOTIDINE TABLET [TEVA PHARMACEUTICALS USA INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFAMOTIDINE TABLET [TEVA PHARMACEUTICALS USA INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFAMOTIDINE TABLET [TEVA PHARMACEUTICALS USA INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8FAMOTIDINE TABLET [TEVA PHARMACEUTICALS USA INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFAMOTIDINE TABLET [TEVA PHARMACEUTICALS USA INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FAMOTIDINE TABLET [TEVA PHARMACEUTICALS USA INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AFAMOTIDINE TABLET [TEVA PHARMACEUTICALS USA INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FAMOTIDINE TABLET [TEVA PHARMACEUTICALS USA INC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FAMOTIDINE TABLET [TEVA PHARMACEUTICALS USA INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFAMOTIDINE TABLET [TEVA PHARMACEUTICALS USA INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UFAMOTIDINE TABLET [TEVA PHARMACEUTICALS USA INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFAMOTIDINE TABLET [TEVA PHARMACEUTICALS USA INC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-2748-94000932748947 BLISTER PACK in 1 CARTON (0093-2748-94) > 10 TABLET, FILM COATED in 1 BLISTER PACK7 blister pack2015-01-082021-11-26NoNoCurrent