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

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
Rxcui199521

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
70771-1654-1vigabatrin100 in 1 BOTTLETABLET, FILM COATED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1654VIGABATRIN TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]2Current NDC, Legacy NDC, 1 package rows20240314_e9c99000-fc0c-4083-b620-ba9ac821f8ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199521vigabatrin 500 MG Oral TabletPSNe9c99000-fc0c-4083-b620-ba9ac821f8ac3
199521vigabatrin 500 MG Oral TabletSCDe9c99000-fc0c-4083-b620-ba9ac821f8ac3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1654-170771165401100 TABLET, FILM COATED in 1 BOTTLE (70771-1654-1) 2022-01-200000-00-00NoNoCurrent