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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEFLUNOMIDE	10 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	G162GK9U4W
Rxcui	205284

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
71335-2874-1	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
71335-2874-1	EA - Each	71335-2874	0a2f1bb8-7cde-4fdc-a82b-581a56feac17	1	2026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
205284	leflunomide 10 MG Oral Tablet	PSN	d0fb9685-9e54-44e5-b543-1077e1a620c6	100
205284	leflunomide 10 MG Oral Tablet	SCD	d0fb9685-9e54-44e5-b543-1077e1a620c6	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2874-1	71335287401	30 TABLET in 1 BOTTLE (71335-2874-1)	30 tablet	2025-10-22	No	No	Current