FDA.reportPublic FDA data

Vigabatrin

Product NDC
59651-366
11-digit product format
596510366
Labeler code
59651
Product ID
59651-366_7fa314e2-0506-4061-9058-435a3b5df40d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vigabatrin
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA213899
Marketing category
ANDA
Marketing start
2021-09-29
Substance
VIGABATRIN
Active strength
500 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vigabatrin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VIGABATRIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGR120KRT6K
Rxcui250820

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
096748f0-965a-4afd-a326-9f691a2861e8Product name120250224
9dea3de0-6f03-9477-9f83-4ffb0883e43fProduct name620240507
9a8c6108-e754-40ae-a629-36a466ae0079Product name820230314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-366-07Vigabatrin1 in 1 PACKETPOWDER, FOR SOLUTION15
59651-366-50Vigabatrin50 in 1 CARTONPOWDER, FOR SOLUTION505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-366-50EA - Each59651-366d80afb29-f533-4d96-be90-037fd6802afb12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-366VIGABATRIN POWDER, FOR SOLUTION [AUROBINDO PHARMA LIMITED]4Current NDC, Legacy NDC, 2 package rows20240121_c97ce40c-1c5a-479d-9188-5ce03cf7e065.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
250820vigabatrin 500 MG Powder for Oral SolutionPSNc97ce40c-1c5a-479d-9188-5ce03cf7e0655
250820vigabatrin 500 MG Powder for Oral SolutionSCDc97ce40c-1c5a-479d-9188-5ce03cf7e0655

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-366-07596510366071 in 1 PACKETHistorical
59651-366-505965103665050 PACKET in 1 CARTON (59651-366-50) / 1 POWDER, FOR SOLUTION in 1 PACKET (59651-366-07) 50 packet2021-09-290000-00-00NoNoCurrent