FDA.reportPublic FDA data

VIGAFYDE

Product NDC
80789-003
11-digit product format
807890003
Labeler code
80789
Product ID
80789-003_43aeb38a-b4ee-47ed-8239-c488b074f1c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vigabatrin
Dosage form
SOLUTION
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
NDA217684
Marketing category
NDA
Marketing start
2024-06-18
Substance
VIGABATRIN
Active strength
100 mg/mL
Pharmacologic classes
Anti-epileptic Agent [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VIGAFYDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VIGABATRIN100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiGR120KRT6K
Rxcui2685217, 2685223

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
80789-003-15VIGAFYDE150 mL in 1 BOTTLESOLUTION15019
80789-003-15VIGAFYDE1 in 1 CARTONSOLUTION119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80789-003-15ML - Milliliter80789-003731ce48e-d5ae-4bf7-ac23-429d6f9939e912024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80789-003VIGAFYDE (VIGABATRIN) SOLUTION [UPSHER-SMITH LABORATORIES, LLC]14Current NDC, 2 package rows20250522_8d3d6316-33ab-41e8-9485-4495c218be56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2685217vigabatrin 100 MG in 1 mL Concentrate for Oral SolutionPSN8d3d6316-33ab-41e8-9485-4495c218be5619
2685223VIGAFYDE 100 MG in 1 mL Concentrate for Oral SolutionPSN8d3d6316-33ab-41e8-9485-4495c218be5619
2685223vigabatrin 100 MG/ML Oral Solution [Vigafyde]SBD8d3d6316-33ab-41e8-9485-4495c218be5619
2685217vigabatrin 100 MG/ML Oral SolutionSCD8d3d6316-33ab-41e8-9485-4495c218be5619
2685217vigabatrin 100 MG per 1 ML Concentrate for Oral SolutionSY8d3d6316-33ab-41e8-9485-4495c218be5619
2685223Vigafyde 100 MG per 1 ML Concentrate for Oral SolutionSY8d3d6316-33ab-41e8-9485-4495c218be5619
2685223Vigafyde 100 MG/ML Oral SolutionSY8d3d6316-33ab-41e8-9485-4495c218be5619

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80789-003-15807890003151 BOTTLE in 1 CARTON (80789-003-15) / 150 mL in 1 BOTTLE1 bottle2024-08-26NoNoCurrent