Home NDC 43598-697 Vigabatrin
Product NDC 43598-697
11-digit product format 435980697
Labeler code 43598
Product ID 43598-697_108f12cf-4bfc-4406-1d50-d57e656f6c8c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vigabatrin
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Dr. Reddy�s Laboratories Inc.,
Application ANDA211481
Marketing category ANDA
Marketing start 2018-11-21
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 A211481-001 VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211481-001 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 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211481-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2018-11-20 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 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 · 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 43598-697-11 Vigabatrin 10 mL in 1 PACKET POWDER, FOR SOLUTION 10 8 43598-697-50 Vigabatrin 50 in 1 CARTON POWDER, FOR SOLUTION 50 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-697 VIGABATRIN POWDER, FOR SOLUTION [DR. REDDY’S LABORATORIES INC.,] 8 Current NDC, Legacy NDC, 2 package rows 20240608_f6be436e-46c7-e9ab-0fcf-e8d04dc12b72.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 43598-697-11 43598069711 10 mL in 1 PACKET 10 ml Historical 43598-697-50 43598069750 50 PACKET in 1 CARTON (43598-697-50) / 10 mL in 1 PACKET (43598-697-11) 50 packet 2018-11-21 0000-00-00 No No Current