Home NDC 80005-167 vigabatrin
Product NDC 80005-167
11-digit product format 800050167
Labeler code 80005
Product ID 80005-167_533a7f8e-4ac6-4688-9ea0-a90626c86ab8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vigabatrin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Carnegie Pharmaceuticals LLC
Application ANDA215519
Marketing category ANDA
Marketing start 2026-02-18
Substance VIGABATRIN
Active strength 500 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A215519-001 VIGABATRIN VIGABATRIN 500MG TABLET / ORAL AB 2023-04-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215519-001 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 2026-02-19 14:30 UTC 2026-02 A215519-001 VIGABATRIN 500MG TABLET / ORAL AB 2023-04-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215519-001 VIGABATRIN 500MG TABLET / ORAL 2023-04-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215519-001 VIGABATRIN 500MG TABLET / ORAL 2023-04-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215519-001 VIGABATRIN 500MG TABLET / ORAL 2023-04-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215519-001 VIGABATRIN 500MG TABLET / ORAL 2023-04-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215519-001 VIGABATRIN 500MG TABLET / ORAL AB 2023-04-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215519-001 VIGABATRIN 500MG TABLET / ORAL AB 2023-04-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215519-001 VIGABATRIN 500MG TABLET / ORAL AB 2023-04-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215519-001 VIGABATRIN 500MG TABLET / ORAL AB 2023-04-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215519-001 VIGABATRIN 500MG TABLET / ORAL AB 2023-04-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215519-001 VIGABATRIN 500MG TABLET / ORAL AB 2023-04-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215519-001 VIGABATRIN 500MG TABLET / ORAL AB 2023-04-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215519-001 VIGABATRIN 500MG TABLET / ORAL AB 2023-04-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215519-001 VIGABATRIN 500MG TABLET / ORAL AB 2023-04-28 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215519-001 VIGABATRIN 500MG TABLET / ORAL AB 2023-04-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215519-001 VIGABATRIN 500MG TABLET / ORAL AB 2023-04-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215519-001 VIGABATRIN 500MG TABLET / ORAL AB 2023-04-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215519-001 VIGABATRIN 500MG TABLET / ORAL AB 2023-04-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215519-001 VIGABATRIN 500MG TABLET / ORAL AB 2023-04-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215519-001 VIGABATRIN 500MG TABLET / ORAL AB 2023-04-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215519-001 VIGABATRIN 500MG TABLET / ORAL AB 2023-04-28 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215519-001 VIGABATRIN 500MG TABLET / ORAL AB 2023-04-28 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base vigabatrin
Listing expiration 2027-12-31 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 80005-167-11 vigabatrin 100 in 1 BOTTLE TABLET, FILM COATED 100 1 80005-167-11 vigabatrin 1 in 1 CARTON TABLET, FILM COATED 1 1
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 Sample Exclude flag Status 80005-167-11 80005016711 1 BOTTLE in 1 CARTON (80005-167-11) / 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2026-02-18 No No Current