FDA.reportPublic FDA data

Teriflunomide

Product NDC
59651-055
11-digit product format
596510055
Labeler code
59651
Product ID
59651-055_86f959a1-cb2b-4df4-b530-094eb486e1d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Teriflunomide
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA209638
Marketing category
ANDA
Marketing start
2023-02-28
Substance
TERIFLUNOMIDE
Active strength
14 mg/1
Pharmacologic classes
Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERIFLUNOMIDE14 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1C058IKG3B
Rxcui1310525, 1310533

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b23dff57-5bec-bcbf-9b41-f1c0342e8e1eProduct name720240514

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-055-28Teriflunomide14 in 1 BLISTER PACKTABLET147
59651-055-28Teriflunomide2 in 1 CARTONTABLET27
59651-055-30Teriflunomide30 in 1 BOTTLETABLET307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-055-30EA - Each59651-05503a5f55a-5f08-4f03-8851-4c3e7b05c5eb12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-055TERIFLUNOMIDE TABLET [AUROBINDO PHARMA LIMITED]6Current NDC, 3 package rows20241107_2fd80242-c607-4c50-b497-8259abb4a2f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1310525teriflunomide 14 MG Oral TabletPSN2fd80242-c607-4c50-b497-8259abb4a2f87
1310533teriflunomide 7 MG Oral TabletPSN2fd80242-c607-4c50-b497-8259abb4a2f87
1310525teriflunomide 14 MG Oral TabletSCD2fd80242-c607-4c50-b497-8259abb4a2f87
1310533teriflunomide 7 MG Oral TabletSCD2fd80242-c607-4c50-b497-8259abb4a2f87

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-055-28596510055282 BLISTER PACK in 1 CARTON (59651-055-28) / 14 TABLET in 1 BLISTER PACK2 blister pack2023-02-28NoNoHistorical
59651-055-305965100553030 TABLET in 1 BOTTLE (59651-055-30) 30 tablet2023-02-28NoNoHistorical