Home NDC 42794-029-08 Disulfiram
Product NDC 42794-029
Requested package NDC 42794-029-08
11-digit product format 427940029
Labeler code 42794
Product ID 42794-029_20208d67-134d-2cc1-e063-6394a90a59be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Disulfiram
Dosage form TABLET
Route ORAL
Labeler Sigmapharm Laboratories, LLC
Application ANDA091619
Marketing category ANDA
Marketing start 2022-01-11
Substance DISULFIRAM
Active strength 500 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 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42794-029 42794-029-08 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091619-001 DISULFIRAM DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 A091619-002 DISULFIRAM DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091619-001 DISULFIRAM 250MG TABLET / ORAL AB 2011-03-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091619-002 DISULFIRAM 500MG TABLET / ORAL AB 2011-03-28 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Disulfiram
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DISULFIRAM 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TR3MLJ1UAI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197623 Internal RxNorm lookup 197624 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42794-029-08 Disulfiram 30 in 1 BOTTLE TABLET 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42794-029 DISULFIRAM TABLET [SIGMAPHARM LABORATORIES, LLC] 4 Current NDC, 1 package rows 20240821_40f5497f-fe84-43b2-8ff4-32d59edf3917.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42794-029-08 42794002908 30 TABLET in 1 BOTTLE (42794-029-08) 30 tablet 2022-01-11 No No Current