Home NDC 0054-0652 Vigabatrin
Product NDC 0054-0652
11-digit product format 000540652
Labeler code 0054
Product ID 0054-0652_f575e137-5300-4e13-a40e-5573f6c8a066
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vigabatrin
Dosage form TABLET
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc
Application ANDA213104
Marketing category ANDA
Marketing start 2022-09-09
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 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 A213104-001 VIGABATRIN VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213104-001 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 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213104-001 VIGABATRIN 500MG TABLET / ORAL AB 2022-08-29 a50c72e98297…
Observed Orange Book normalized TE history# 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 0054-0652-25 Vigabatrin 100 in 1 BOTTLE TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0652 VIGABATRIN TABLET [HIKMA PHARMACEUTICALS USA INC] 2 Current NDC, Legacy NDC, 1 package rows 20240922_5ed8d293-b7d8-4c66-9c31-8075e6f99092.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 Marketing end Sample Exclude flag Status 0054-0652-25 00054065225 100 TABLET in 1 BOTTLE (0054-0652-25) 100 tablet 2022-09-09 0000-00-00 No No Current