vigabatrin

Product NDC
70771-1654
11-digit product format
707711654
Labeler code
70771
Product ID
70771-1654_5eea977c-802f-4fdf-9ad3-70a4e2f1cf1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vigabatrin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA215707
Marketing category
ANDA
Marketing start
2022-01-20
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
GR120KRT6KVIGABATRIN68506-86-5VIGABATRIN

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70771-1654-170771165401100 TABLET, FILM COATED in 1 BOTTLE (70771-1654-1) 2022-01-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
vigabatrinZydus Lifesciences Limited2025-11-07HUMAN PRESCRIPTION DRUG LABEL3
vigabatrinZydus Lifesciences Limited2024-03-13HUMAN PRESCRIPTION DRUG LABEL2