FDA.reportPublic FDA data

VIGABATRIN

Product NDC
0574-0470
Requested package NDC
0574-0470-50
11-digit product format
005740470
Labeler code
0574
Product ID
0574-0470_3d6b0f6d-7352-43ee-ae54-3baed45212ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vigabatrin
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Padagis US LLC
Application
ANDA214992
Marketing category
ANDA
Marketing start
2022-06-29
Marketing end
0000-00-00
Substance
VIGABATRIN
Active strength
500 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0574-04700574-0470-50DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A214992-001VIGABATRINVIGABATRIN500MG/PACKETFOR SOLUTION / ORAL2021-05-13

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A214992-001VIGABATRIN500MG/PACKETFOR SOLUTION / ORAL2021-05-13a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-0470-50EA - Each0574-0470a807b89e-9350-4794-85ec-df15b5b0aacb12021-11-09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0574-0470-500057404705050 POWDER, FOR SOLUTION in 1 CARTON (0574-0470-50) 2022-06-290000-00-00NoNoCurrent