FDA.reportPublic FDA data

TERIFLUNOMIDE

Product NDC
46708-314
11-digit product format
467080314
Labeler code
46708
Product ID
46708-314_5c2a05ed-ff36-4dce-97e9-77b2d948b4f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TERIFLUNOMIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA209572
Marketing category
ANDA
Marketing start
2023-01-25
Substance
TERIFLUNOMIDE
Active strength
14 mg/1
Pharmacologic classes
Dihydroorotate Dehydrogenase Inhibitors [MoA], Pyrimidine Synthesis Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TERIFLUNOMIDE
Listing expiration
2026-12-31

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
46708-314-14TERIFLUNOMIDE14 in 1 BLISTER PACKTABLET, FILM COATED144
46708-314-14TERIFLUNOMIDE2 in 1 CARTONTABLET, FILM COATED24
46708-314-30TERIFLUNOMIDE30 in 1 BOTTLETABLET, FILM COATED304
46708-314-91TERIFLUNOMIDE1000 in 1 BOTTLETABLET, FILM COATED10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-314TERIFLUNOMIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]4Current NDC, 4 package rows20230209_2b084b44-f15b-4b16-b700-4382434f2136.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1310525teriflunomide 14 MG Oral TabletPSN2b084b44-f15b-4b16-b700-4382434f21364
1310533teriflunomide 7 MG Oral TabletPSN2b084b44-f15b-4b16-b700-4382434f21364
1310525teriflunomide 14 MG Oral TabletSCD2b084b44-f15b-4b16-b700-4382434f21364
1310533teriflunomide 7 MG Oral TabletSCD2b084b44-f15b-4b16-b700-4382434f21364

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-314-14467080314142 BLISTER PACK in 1 CARTON (46708-314-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2023-01-25NoNoCurrent
46708-314-304670803143030 TABLET, FILM COATED in 1 BOTTLE (46708-314-30) 2023-01-25NoNoCurrent
46708-314-91467080314911000 TABLET, FILM COATED in 1 BOTTLE (46708-314-91) 2023-01-25NoNoCurrent