Home NDC 70710-1494 vigabatrin
Product NDC 70710-1494
11-digit product format 707101494
Labeler code 70710
Product ID 70710-1494_b41c9be1-67c2-416e-ae53-5c31eafb8e10
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vigabatrin
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Zydus Pharmaceuticals (USA) Inc.
Application ANDA214671
Marketing category ANDA
Marketing start 2025-03-24
Substance VIGABATRIN
Active strength 500 mg/10mL
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 A214671-001 VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02
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.
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 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2023-03-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2023-03-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2023-03-02 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214671-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL 2023-03-02 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214671-001 AA 1 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214671-001 AA 1 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214671-001 AA 1 053a50430f4f…
Additional Listing Data#
Finished product Yes
Brand name base vigabatrin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VIGABATRIN 500 mg/10mL
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 70710-1494-1 vigabatrin 10 mL in 1 PACKET POWDER, FOR SOLUTION 10 2 70710-1494-8 vigabatrin 50 in 1 CARTON POWDER, FOR SOLUTION 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-1494 VIGABATRIN POWDER, FOR SOLUTION [ZYDUS PHARMACEUTICALS (USA) INC.] 2 Current NDC, 2 package rows 20250325_6d3fc853-1b2d-47ad-a4f2-f11505601bc2.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70710-1494-1 70710149401 10 mL in 1 PACKET 10 ml Historical 70710-1494-8 70710149408 50 PACKET in 1 CARTON (70710-1494-8) / 10 mL in 1 PACKET (70710-1494-1) 50 packet 2025-03-24 No No Current