leflunomide

Product NDC
72162-2410
11-digit product format
721622410
Labeler code
72162
Product ID
72162-2410_fbe46801-abce-4841-875d-117a53c89651
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
20 mg/1
Pharmacologic classes
Antirheumatic Agent [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEFLUNOMIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG162GK9U4W
Rxcui205285

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
07b45089-afbe-518f-59f0-bf5b3c5b5d4eProduct name420210927

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2410-3leflunomide30 in 1 BOTTLETABLET30102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2410-3EA - Each72162-24108f7ae127-2384-47e9-b7c3-8a34c5d34c4312024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2410LEFLUNOMIDE TABLET [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20250108_91712aad-d96c-4ef0-97e7-b31ed18ca6d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205285leflunomide 20 MG Oral TabletPSN91712aad-d96c-4ef0-97e7-b31ed18ca6d8102
205285leflunomide 20 MG Oral TabletSCD91712aad-d96c-4ef0-97e7-b31ed18ca6d8102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2410-37216224100330 TABLET in 1 BOTTLE (72162-2410-3) 30 tablet2009-10-29NoNoHistorical