Vigabatrin

Product NDC
60219-1425
11-digit product format
602191425
Labeler code
60219
Product ID
60219-1425_3bf642d5-5597-4668-a4ab-d240699a395e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vigabatrin
Dosage form
FOR SOLUTION
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA210155
Marketing category
ANDA
Marketing start
2023-12-07
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
60219-1425-5Vigabatrin50 in 1 CARTONFOR SOLUTION502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-1425-5EA - Each60219-1425ba73b7e3-d93a-4063-bfa1-9cfb1f5253ae12024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-1425VIGABATRIN FOR SOLUTION [AMNEAL PHARMACEUTICALS NY LLC]2Current NDC, 1 package rows20250503_9791494f-492b-487a-8211-7747fb57923e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
250820vigabatrin 500 MG Powder for Oral SolutionPSN9791494f-492b-487a-8211-7747fb57923e2
250820vigabatrin 500 MG Powder for Oral SolutionSCD9791494f-492b-487a-8211-7747fb57923e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60219-1425-56021914250550 FOR SOLUTION in 1 CARTON (60219-1425-5) 50 for solution2023-12-07NoNoHistorical