Home NDC 67386-211 SABRIL
Product NDC 67386-211
11-digit product format 673860211
Labeler code 67386
Product ID 67386-211_d2901195-e325-4ca5-8453-b020a77ba6aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vigabatrin
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Lundbeck Pharmaceuticals LLC
Application NDA022006
Marketing category NDA
Marketing start 2009-08-21
Substance VIGABATRIN
Active strength 50 mg/mL
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 N022006-001 SABRIL VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 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 N022006-001 AA
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 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA RLD, RS 2009-08-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022006-001 SABRIL 500MG/PACKET FOR SOLUTION / ORAL AA 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 50 mg/mL
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 250820 Internal RxNorm lookup 860898 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 67386-211-65 SABRIL 50 in 1 CARTON POWDER, FOR SOLUTION 50 46 67386-211-65 SABRIL 10 mL in 1 PACKET POWDER, FOR SOLUTION 10 46
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67386-211 SABRIL (VIGABATRIN) POWDER, FOR SOLUTION [LUNDBECK PHARMACEUTICALS LLC] 42 Current NDC, Legacy NDC, 2 package rows 20241222_a88ac1b4-e2c9-45c0-b321-4785902172e3.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 a88ac1b4-e2c9-45c0-b321-4785902172e3 2021-10-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022006 application number: NDA022006 ndc (product): 67386-211
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 67386-211-65 67386021165 50 PACKET in 1 CARTON (67386-211-65) / 10 mL in 1 PACKET 50 packet 2009-08-21 0000-00-00 No No Current