Vigabatrin

Product NDC
43598-651
11-digit product format
435980651
Labeler code
43598
Product ID
43598-651_f9d29bec-f73b-7dc9-5f1b-7857dc0fdb74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vigabatrin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy�s Laboratories Inc.,
Application
ANDA211539
Marketing category
ANDA
Marketing start
2021-02-01
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
43598-651-01Vigabatrin100 in 1 BOTTLETABLET, FILM COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-651-01EA - Each43598-651a51b7260-323e-4e28-abc0-59d3b860ac3912021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-651VIGABATRIN TABLET, FILM COATED [DR. REDDY’S LABORATORIES INC.,]4Current NDC, Legacy NDC, 1 package rows20210203_0afdc84c-f8ec-330a-31c9-fac4ed256931.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199521vigabatrin 500 MG Oral TabletPSN0afdc84c-f8ec-330a-31c9-fac4ed2569314
199521vigabatrin 500 MG Oral TabletSCD0afdc84c-f8ec-330a-31c9-fac4ed2569314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-651-0143598065101100 TABLET, FILM COATED in 1 BOTTLE (43598-651-01) 2021-02-010000-00-00NoNoCurrent