teriflunomide

Product NDC
68462-311
11-digit product format
684620311
Labeler code
68462
Product ID
68462-311_547ff1b7-72fc-4820-b337-d8ee0202fefe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
teriflunomide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA209663
Marketing category
ANDA
Marketing start
2020-05-01
Marketing end
0000-00-00
Substance
TERIFLUNOMIDE
Active strength
7 mg/1
Pharmacologic classes
Pyrimidine Synthesis Inhibitor [EPC],Dihydroorotate Dehydrogenase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-311-84684620311842 BLISTER PACK in 1 CARTON (68462-311-84) > 14 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2020-05-010000-00-00NoNoCurrent
68462-311-85684620311851 BLISTER PACK in 1 CARTON (68462-311-85) > 5 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2020-05-010000-00-00NoNoCurrent