Antabuse

Product NDC
51285-523
11-digit product format
512850523
Labeler code
51285
Product ID
51285-523_f94e573e-5f61-47c9-8e9c-be1ce5aa49ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Disulfiram
Dosage form
TABLET
Route
ORAL
Labeler
Teva Women's Health, Inc.
Application
ANDA088482
Marketing category
ANDA
Marketing start
2000-12-01
Marketing end
2021-11-30
Substance
DISULFIRAM
Active strength
250 mg/1
Pharmacologic classes
Acetyl Aldehyde Dehydrogenase Inhibitors [MoA],Aldehyde Dehydrogenase Inhibitor [EPC]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51285-523DDiscontinued by firm2026-08-11
excluded packagepackage51285-52351285-523-02DDiscontinued by firm2026-08-11

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 · 24 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 packagepackage51285-523-02d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51285-523-02f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51285-523-022ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51285-523-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51285-523-02cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51285-523-02cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51285-523-02302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51285-523-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51285-523-020efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51285-523-02ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51285-523-02367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51285-523-02557ba5c1ecfa…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
A088482-001ANTABUSEDISULFIRAM250MGTABLET / ORALRLD1983-12-08

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 UTC2026-02A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A088482-001ANTABUSE250MGTABLET / ORALAB1983-12-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088482-001ANTABUSE250MGTABLET / ORALAB1983-12-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A088482-001ANTABUSE250MGTABLET / ORALAB1983-12-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088482-001ANTABUSE250MGTABLET / ORALAB1983-12-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088482-001ANTABUSE250MGTABLET / ORALAB1983-12-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088482-001ANTABUSE250MGTABLET / ORALAB1983-12-083f01610625f2…
2019-09-15 20:21 UTC2019-09A088482-001ANTABUSE250MGTABLET / ORALAB1983-12-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A088482-001ANTABUSE250MGTABLET / ORALAB1983-12-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088482-001ANTABUSE250MGTABLET / ORALRLD1983-12-08cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A088482-001AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A088482-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A088482-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A088482-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A088482-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A088482-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A088482-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A088482-001AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1abf4562-030c-45f5-a6c4-ba508de7c203Product name120150413

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51285-523-02EA - Each51285-523a842ae07-bb61-415b-aecc-19295de4401012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DISULFIRAMACTIVE INGREDIENTTR3MLJ1UAIANTABUSE (DISULFIRAM) TABLET [TEVA WOMEN'S HEALTH, INC.]8
DISULFIRAMACTIVE MOIETYTR3MLJ1UAIANTABUSE (DISULFIRAM) TABLET [TEVA WOMEN'S HEALTH, INC.]8
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKANTABUSE (DISULFIRAM) TABLET [TEVA WOMEN'S HEALTH, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UANTABUSE (DISULFIRAM) TABLET [TEVA WOMEN'S HEALTH, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANTABUSE (DISULFIRAM) TABLET [TEVA WOMEN'S HEALTH, INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ANTABUSE (DISULFIRAM) TABLET [TEVA WOMEN'S HEALTH, INC.]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ANTABUSE (DISULFIRAM) TABLET [TEVA WOMEN'S HEALTH, INC.]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APANTABUSE (DISULFIRAM) TABLET [TEVA WOMEN'S HEALTH, INC.]8
DISULFIRAMACTIVE INGREDIENTTR3MLJ1UAIANTABUSE (DISULFIRAM) TABLET [PHYSICIANS TOTAL CARE, INC.]1
DISULFIRAMACTIVE MOIETYTR3MLJ1UAIANTABUSE (DISULFIRAM) TABLET [PHYSICIANS TOTAL CARE, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKANTABUSE (DISULFIRAM) TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UANTABUSE (DISULFIRAM) TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANTABUSE (DISULFIRAM) TABLET [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ANTABUSE (DISULFIRAM) TABLET [PHYSICIANS TOTAL CARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ANTABUSE (DISULFIRAM) TABLET [PHYSICIANS TOTAL CARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APANTABUSE (DISULFIRAM) TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
210628Antabuse 250 MG Oral TabletPSN12850de3-c97c-42c1-b8d3-55dc6fd057501
197623disulfiram 250 MG Oral TabletPSN12850de3-c97c-42c1-b8d3-55dc6fd057501
210628disulfiram 250 MG Oral Tablet [Antabuse]SBD12850de3-c97c-42c1-b8d3-55dc6fd057501
197623disulfiram 250 MG Oral TabletSCD12850de3-c97c-42c1-b8d3-55dc6fd057501
210628Antabuse 250 MG Oral TabletSY12850de3-c97c-42c1-b8d3-55dc6fd057501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51285-523-0251285052302100 TABLET in 1 BOTTLE (51285-523-02) 100 tablet2000-12-012021-11-30NoNoCurrent