Home NDC 0574-0201-01 VIGABATRIN
Product NDC 0574-0201
Requested package NDC 0574-0201-01
11-digit product format 005740201
Labeler code 0574
Product ID 0574-0201_05bc949b-e493-4379-a134-a000d134cf22
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vigabatrin
Dosage form TABLET
Route ORAL
Labeler Padagis US LLC
Application ANDA215109
Marketing category ANDA
Marketing start 2022-06-29
Marketing end 0000-00-00
Substance VIGABATRIN
Active strength 500 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A215109-001 VIGABATRIN VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215109-001 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.
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 2026-08-18 06:07:40 2026-07 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215109-001 VIGABATRIN 500MG TABLET / ORAL AB 2021-09-23 a50c72e98297…
Observed Orange Book normalized TE history# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vigabatrin VIGABATRIN Edenbridge Pharmaceuticals LLC. 93ba3894-fd97-4432-9f2d-e7050371e91f 2026-08-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 215109 application number: ANDA215109
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0574-0201-01 00574020101 100 TABLET in 1 BOTTLE (0574-0201-01) 100 tablet 2022-06-29 0000-00-00 No No Current