FDA.reportPublic FDA data

TERIFLUNOMIDE

Product NDC
62332-314
11-digit product format
623320314
Labeler code
62332
Product ID
62332-314_95e1ed70-9c5b-4bad-a26e-b33cd3f9b7ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TERIFLUNOMIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
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
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
62332-314-14TERIFLUNOMIDE2 in 1 CARTONTABLET, FILM COATED218
62332-314-14TERIFLUNOMIDE14 in 1 BLISTER PACKTABLET, FILM COATED1418
62332-314-30TERIFLUNOMIDE30 in 1 BOTTLETABLET, FILM COATED3018
62332-314-91TERIFLUNOMIDE1000 in 1 BOTTLETABLET, FILM COATED100018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-314TERIFLUNOMIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]17Current NDC, 4 package rows20250406_8c1bc23b-a62b-4172-a603-8b97761514b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1310525teriflunomide 14 MG Oral TabletPSN8c1bc23b-a62b-4172-a603-8b97761514b418
1310533teriflunomide 7 MG Oral TabletPSN8c1bc23b-a62b-4172-a603-8b97761514b418
1310525teriflunomide 14 MG Oral TabletSCD8c1bc23b-a62b-4172-a603-8b97761514b418
1310533teriflunomide 7 MG Oral TabletSCD8c1bc23b-a62b-4172-a603-8b97761514b418

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62332-314-14623320314142 BLISTER PACK in 1 CARTON (62332-314-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2023-01-25NoNoCurrent
62332-314-306233203143030 TABLET, FILM COATED in 1 BOTTLE (62332-314-30) 2023-01-25NoNoCurrent
62332-314-91623320314911000 TABLET, FILM COATED in 1 BOTTLE (62332-314-91) 2023-01-25NoNoCurrent