FDA.reportPublic FDA data

rufinamide

Product NDC
68462-713
11-digit product format
684620713
Labeler code
68462
Product ID
68462-713_18421d5f-9e93-4abb-8abe-855bab5d243e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rufinamide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA205075
Marketing category
ANDA
Marketing start
2016-05-16
Substance
RUFINAMIDE
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RUFINAMIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWFW942PR79
Rxcui824295, 824301

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
131b7904-af2d-e086-e6ed-019008086140Product name920260127

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-713-05rufinamide500 in 1 BOTTLETABLET, FILM COATED5004
68462-713-08rufinamide120 in 1 BOTTLETABLET, FILM COATED1204
68462-713-30rufinamide30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-713-08EA - Each68462-71329c7600b-e394-444a-8069-e2a28b2e860d12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-713RUFINAMIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]3Current NDC, Legacy NDC, 3 package rows20240104_da9ee326-a383-4d46-9d4e-fcc2be3d2680.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
824295rufinamide 200 MG Oral TabletPSNda9ee326-a383-4d46-9d4e-fcc2be3d26804
824301rufinamide 400 MG Oral TabletPSNda9ee326-a383-4d46-9d4e-fcc2be3d26804
824295rufinamide 200 MG Oral TabletSCDda9ee326-a383-4d46-9d4e-fcc2be3d26804
824301rufinamide 400 MG Oral TabletSCDda9ee326-a383-4d46-9d4e-fcc2be3d26804

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-713-0568462071305500 TABLET, FILM COATED in 1 BOTTLE (68462-713-05) 2016-05-160000-00-00NoNoCurrent
68462-713-0868462071308120 TABLET, FILM COATED in 1 BOTTLE (68462-713-08) 2016-05-160000-00-00NoNoCurrent
68462-713-306846207133030 TABLET, FILM COATED in 1 BOTTLE (68462-713-30) 2016-05-160000-00-00NoNoCurrent