Home NDC 0591-3955-00 vigabatrin
Product NDC 0591-3955
Requested package NDC 0591-3955-00
11-digit product format 005913955
Labeler code 0591
Product ID 0591-3955_bb26e312-15c4-4764-ae8b-b309c3d8d362
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vigabatrin
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA209824
Marketing category ANDA
Marketing start 2020-05-14
Marketing end 0000-00-00
Substance VIGABATRIN
Active strength 50 mg/mL
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 · 21 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 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 5b2001dcd8f5…54b53d4dc9e4…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A209824-001 VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2018-04-23
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 · 43 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 2026-09-14 22:38:34 2026-08 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2018-04-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2018-04-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2018-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209824-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-04-23 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product No
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VIGABATRIN 50 mg/mL
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-3955 VIGABATRIN POWDER, FOR SOLUTION [ACTAVIS PHARMA, INC.] 8 Legacy NDC 20230615_1ce1c52d-441a-4ed7-afff-568192197454.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Status 0591-3955-00 00591395500 10 mL in 1 BOX (0591-3955-00) 10 ml 23-APR-18 Current