Home NDC 0245-0556 VIGADRONE
Product NDC 0245-0556
11-digit product format 002450556
Labeler code 0245
Product ID 0245-0556_3aae9c74-44ec-cc53-e063-6294a90a5538
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vigabatrin
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA210196
Marketing category ANDA
Marketing start 2018-06-21
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 A210196-001 VIGADRONE VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210196-001 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 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210196-001 VIGADRONE 500MG/PACKET FOR SOLUTION / ORAL AA 2018-06-21 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 VIGADRONE
Listing expiration 2027-12-31 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 2047868 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 0245-0556-50 VIGADRONE 50 in 1 CARTON POWDER, FOR SOLUTION 50 8 0245-0556-89 VIGADRONE 10 mL in 1 PACKET POWDER, FOR SOLUTION 10 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0245-0556 VIGADRONE (VIGABATRIN) POWDER, FOR SOLUTION [UPSHER-SMITH LABORATORIES, LLC] 7 Current NDC, Legacy NDC, 2 package rows 20241121_5e5e7554-d0f4-47f7-a434-cc5ca5a9826f.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 0245-0556-50 00245055650 50 PACKET in 1 CARTON (0245-0556-50) / 10 mL in 1 PACKET (0245-0556-89) 50 packet 2018-06-21 0000-00-00 No No Current 0245-0556-89 00245055689 10 mL in 1 PACKET 10 ml Historical