leflunomide

Product NDC: 71335-2832
11-digit product format: 713352832
Labeler code: 71335
Product ID: 71335-2832_a057209f-4e79-48e8-a749-60772266b573
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: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEFLUNOMIDE	20 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	G162GK9U4W
Rxcui	205285

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
07b45089-afbe-518f-59f0-bf5b3c5b5d4e	Product name	4	20210927

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71335-2832-1	leflunomide	30 in 1 BOTTLE	TABLET	30		100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-2832-1	EA - Each	71335-2832	8f9496d1-ba16-4895-970b-447849483118	1	2026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
205285	leflunomide 20 MG Oral Tablet	PSN	fa5f71b3-6a56-4616-baf7-4b761023b2a9	100
205285	leflunomide 20 MG Oral Tablet	SCD	fa5f71b3-6a56-4616-baf7-4b761023b2a9	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2832-1	71335283201	30 TABLET in 1 BOTTLE (71335-2832-1)	30 tablet	2025-10-22	No	No	Historical