Home NDC 31722-009 vigabatrin for oral solution
Product NDC 31722-009
11-digit product format 317220009
Labeler code 31722
Product ID 31722-009_16ae8082-260c-b789-e063-6294a90ab6e8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vigabatrin
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA213519
Marketing category ANDA
Marketing start 2021-01-26
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 1 .
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 A213519-001 VIGABATRIN VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2021-01-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213519-001 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.
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 2026-08-01 22:54:32 2026-06 A213519-001 VIGABATRIN 500MG/PACKET FOR SOLUTION / ORAL AA 2021-01-26 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A213519-001 AA 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base vigabatrin for oral solution
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 31722-009-50 vigabatrin for oral solution 50 in 1 CARTON POWDER, FOR SOLUTION 50 2 31722-009-50 vigabatrin for oral solution 10 mL in 1 PACKET POWDER, FOR SOLUTION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-009 VIGABATRIN FOR ORAL SOLUTION (VIGABATRIN) POWDER, FOR SOLUTION [CAMBER PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20240424_bda491b6-47ba-400b-9816-b6d15c6e2683.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 31722-009-50 31722000950 50 PACKET in 1 CARTON (31722-009-50) / 10 mL in 1 PACKET 50 packet 2021-01-26 0000-00-00 No No Current