Home NDC 67386-111 SABRIL
Product NDC 67386-111
11-digit product format 673860111
Labeler code 67386
Product ID 67386-111_09c27a1b-5916-4e16-a9a3-924099661be6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vigabatrin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lundbeck Pharmaceuticals LLC
Application NDA020427
Marketing category NDA
Marketing start 2009-08-21
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 N020427-001 SABRIL VIGABATRIN 500MG TABLET / ORAL AB RLD, RS 2009-08-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020427-001 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 · 42 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 2026-08-18 06:07:40 2026-07 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020427-001 SABRIL 500MG TABLET / ORAL AB RLD, RS 2009-08-21 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base SABRIL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199521 Internal RxNorm lookup 860895 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 67386-111-01 SABRIL 100 in 1 BOTTLE TABLET, FILM COATED 100 40
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VIGABATRIN ACTIVE INGREDIENT GR120KRT6K SABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK LLC] 11 VIGABATRIN ACTIVE MOIETY GR120KRT6K SABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK LLC] 11 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK LLC] 11 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK LLC] 11 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK LLC] 11 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK LLC] 11 POVIDONES INACTIVE INGREDIENT FZ989GH94E SABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK LLC] 11 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 SABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK LLC] 11 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK LLC] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67386-111 SABRIL (VIGABATRIN) TABLET, FILM COATED [LUNDBECK PHARMACEUTICALS LLC] 36 Current NDC, Legacy NDC, 1 package rows 20241222_a5d389d2-d0e1-4395-a2a2-b552808e7f98.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SABRIL VIGABATRIN Lundbeck Pharmaceuticals LLC a5d389d2-d0e1-4395-a2a2-b552808e7f98 2021-10-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020427 application number: NDA020427 ndc (product): 67386-111
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 67386-111-01 67386011101 100 TABLET, FILM COATED in 1 BOTTLE (67386-111-01) 2009-08-21 0000-00-00 No No Current