Home NDC 63629-5466 Disulfiram
Product NDC 63629-5466
11-digit product format 636295466
Labeler code 63629
Product ID 63629-5466_0102cfcc-e278-4a05-8588-d27b68f8bf78
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Disulfiram
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091681-001 DISULFIRAM DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091681-001 AB
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 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 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091681-001 DISULFIRAM 250MG TABLET / ORAL AB 2013-08-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 250 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197623 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 63629-5466-1 Disulfiram 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-5466 DISULFIRAM TABLET [BRYANT RANCH PREPACK] 1 Current NDC, 1 package rows 20250410_bd09ba63-7eef-4740-b5e9-383887024f1f.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 63629-5466-1 63629546601 90 TABLET in 1 BOTTLE (63629-5466-1) 90 tablet 2025-04-07 No No Current