Disulfiram

Product NDC
47781-607
11-digit product format
477810607
Labeler code
47781
Product ID
47781-607_77d10056-3423-1662-dea6-e40339965ca8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Disulfiram
Dosage form
TABLET
Route
ORAL
Labeler
Alvogen Inc.
Application
ANDA091681
Marketing category
ANDA
Marketing start
2013-08-09
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
2026-12-31
Current FDA listing
Yes

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 packagepackage47781-60747781-607-01DDiscontinued 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 · 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
A091681-001DISULFIRAMDISULFIRAM250MGTABLET / ORALAB2013-08-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A091681-001AB

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 UTC2026-02A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-083f01610625f2…
2019-09-15 20:21 UTC2019-09A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091681-001DISULFIRAM250MGTABLET / ORALAB2013-08-08cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091681-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091681-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091681-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091681-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091681-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091681-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091681-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091681-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091681-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091681-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091681-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091681-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091681-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091681-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091681-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091681-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091681-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091681-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091681-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091681-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091681-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091681-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091681-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091681-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091681-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091681-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091681-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091681-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091681-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091681-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091681-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091681-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091681-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091681-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091681-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091681-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091681-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091681-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091681-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091681-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Disulfiram
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DISULFIRAM250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TR3MLJ1UAIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197623Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b90f8ff4-4fb3-46ab-8149-cb55f24a4044Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47781-607-01Disulfiram100 in 1 BOTTLETABLET10014
47781-607-30Disulfiram30 in 1 BOTTLE, PLASTICTABLET3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-607-30EA - Each47781-607fe50d588-858a-4c43-8221-c6c78786849c12013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DISULFIRAMACTIVE INGREDIENTTR3MLJ1UAIDISULFIRAM TABLET [ALVOGEN INC.]5
DISULFIRAMACTIVE MOIETYTR3MLJ1UAIDISULFIRAM TABLET [ALVOGEN INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDISULFIRAM TABLET [ALVOGEN INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDISULFIRAM TABLET [ALVOGEN INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DISULFIRAM TABLET [ALVOGEN INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DISULFIRAM TABLET [ALVOGEN INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DISULFIRAM TABLET [ALVOGEN INC.]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDISULFIRAM TABLET [ALVOGEN INC.]5
DISULFIRAMACTIVE INGREDIENTTR3MLJ1UAIDISULFIRAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
DISULFIRAMACTIVE MOIETYTR3MLJ1UAIDISULFIRAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDISULFIRAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDISULFIRAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DISULFIRAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DISULFIRAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DISULFIRAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDISULFIRAM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-607DISULFIRAM TABLET [ALVOGEN INC.]13Current NDC, Legacy NDC, 2 package rows20241016_b90f8ff4-4fb3-46ab-8149-cb55f24a4044.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DisulfiramDISULFIRAMGolden State Medical Supply, Inc.d3832a1a-a140-49c1-a7df-134fa81341e32026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091681
application number: ANDA091681
DisulfiramDISULFIRAMAlvogen Inc.b90f8ff4-4fb3-46ab-8149-cb55f24a40442025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091681
application number: ANDA091681
ndc (product): 47781-607
DisulfiramDISULFIRAMBryant Ranch Prepackbd09ba63-7eef-4740-b5e9-383887024f1f2025-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091681
application number: ANDA091681

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197623disulfiram 250 MG Oral TabletPSNb90f8ff4-4fb3-46ab-8149-cb55f24a404414
197623disulfiram 250 MG Oral TabletSCDb90f8ff4-4fb3-46ab-8149-cb55f24a404414
197623disulfiram 250 MG Oral TabletPSNd3832a1a-a140-49c1-a7df-134fa81341e311
197623disulfiram 250 MG Oral TabletSCDd3832a1a-a140-49c1-a7df-134fa81341e311
197623disulfiram 250 MG Oral TabletPSNbd09ba63-7eef-4740-b5e9-383887024f1f1
197623disulfiram 250 MG Oral TabletSCDbd09ba63-7eef-4740-b5e9-383887024f1f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-607-0147781060701100 in 1 BOTTLEHistorical
47781-607-304778106073030 TABLET in 1 BOTTLE, PLASTIC (47781-607-30) 30 tablet2013-08-090000-00-00NoNoCurrent