Home NDC 49884-358 VIGABATRIN
Product NDC 49884-358
11-digit product format 498840358
Labeler code 49884
Product ID 49884-358_5d250019-9b68-4240-b9ea-165c37690ecf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vigabatrin
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Par Health USA, LLC
Application ANDA208218
Marketing category ANDA
Marketing start 2017-04-27
Substance VIGABATRIN
Active strength 50 mg/mL
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 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 A208218-001 VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208218-001 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 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 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 VIGABATRIN
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 250820 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 49884-358-03 VIGABATRIN 50 in 1 CARTON POWDER, FOR SOLUTION 50 29 49884-358-52 VIGABATRIN 10 mL in 1 PACKET POWDER, FOR SOLUTION 10 29
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49884-358 VIGABATRIN POWDER, FOR SOLUTION [ENDO USA, INC.] 28 Current NDC, Legacy NDC, 2 package rows 20240523_e7cbc0a5-8c28-4451-9176-b608e228ba66.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 49884-358-03 49884035803 50 PACKET in 1 CARTON (49884-358-03) / 10 mL in 1 PACKET (49884-358-52) 50 packet 2017-04-27 0000-00-00 No No Current 49884-358-52 49884035852 10 mL in 1 PACKET 10 ml Historical