leflunomide

Product NDC
71335-2874
11-digit product format
713352874
Labeler code
71335
Product ID
71335-2874_c09fb831-4b93-47e8-9c95-2082c73ce4c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
leflunomide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077086
Marketing category
ANDA
Marketing start
2009-10-29
Substance
LEFLUNOMIDE
Active strength
10 mg/1
Pharmacologic classes
Antirheumatic Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
G162GK9U4WLEFLUNOMIDE75706-12-6LEFLUNOMIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2874-17133528740130 TABLET in 1 BOTTLE (71335-2874-1) 30 tablet2025-10-22NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
leflunomideBryant Ranch Prepack2025-10-22HUMAN PRESCRIPTION DRUG LABEL100