Home NDC 49884-358 VIGABATRIN
Product NDC 49884-358
11-digit product format 498840358
Labeler code 49884
Product ID 49884-358_c96e1536-adc6-4318-a40f-7542b80313ee
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 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 A208218-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2017-04-27 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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
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