Home NDC 0591-3851 Vigabatrin
Product NDC 0591-3851
11-digit product format 005913851
Labeler code 0591
Product ID 0591-3851_c29a7450-ee68-466a-a33f-bf5065da1593
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vigabatrin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA209822
Marketing category ANDA
Marketing start 2019-02-06
Substance VIGABATRIN
Active strength 500 mg/1
Pharmacologic classes Anti-epileptic Agent [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 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 0591-3851 UNFINISHED Active or certified unfinished drug listing 2026-10-05 unfinished package package 0591-3851 0591-3851-77 UNFINISHED Active or certified unfinished drug listing 2026-10-05
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 · 53 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A209822-001 VIGABATRIN VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209822-001 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 · 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 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209822-001 VIGABATRIN 500MG TABLET / ORAL AB 2019-01-14 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Vigabatrin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VIGABATRIN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination GR120KRT6K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199521 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 0591-3851-01 Vigabatrin 100 in 1 BOTTLE TABLET, FILM COATED 100 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-3851 VIGABATRIN TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 13 Current NDC, Legacy NDC, 1 package rows 20250507_8dc7bd15-2636-4d58-b651-dd117ca43dbd.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 Marketing start Marketing end Sample Exclude flag Status 0591-3851-01 00591385101 100 TABLET, FILM COATED in 1 BOTTLE (0591-3851-01) 2019-02-06 0000-00-00 No No Current 0591-3851-77 00591385177 16956 TABLET, FILM COATED in 1 CONTAINER (0591-3851-77) 22-AUG-24 31-MAY-27 Historical