FDA.reportPublic FDA data

vigabatrin

Product NDC
0591-3955
Requested package NDC
0591-3955-50
11-digit product format
005913955
Labeler code
0591
Product ID
0591-3955_bb26e312-15c4-4764-ae8b-b309c3d8d362
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vigabatrin
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA209824
Marketing category
ANDA
Marketing start
2020-05-14
Marketing end
0000-00-00
Substance
VIGABATRIN
Active strength
50 mg/mL
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 packagepackage0591-39550591-3955-50DDiscontinued 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
A209824-001VIGABATRINVIGABATRIN500MG/PACKETFOR SOLUTION / ORAL2018-04-23

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 22:54:322026-06A209824-001VIGABATRIN500MG/PACKETFOR SOLUTION / ORAL2018-04-23a50c72e98297…

Additional Listing Data#

Finished product
No
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VIGABATRIN50 mg/mL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3955-11EA - Each0591-3955076a9339-32ec-4751-b0cb-c4c7ee27431012020-06-05
0591-3955-50EA - Each0591-3955139ea3b2-44db-4017-8be5-6d67e067785212020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3955VIGABATRIN POWDER, FOR SOLUTION [ACTAVIS PHARMA, INC.]8Legacy NDC20230615_1ce1c52d-441a-4ed7-afff-568192197454.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-3955-500059139555050 PACKET in 1 CARTON (0591-3955-50) > 10 mL in 1 PACKET (0591-3955-11) 50 packet2020-05-140000-00-00NoNoCurrent