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NDC 70710-1158-01 leflunomide 20 mg/1 Details

leflunomide 20 mg/1

leflunomide is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals (USA) Inc.. The primary component is LEFLUNOMIDE.

MedlinePlus Drug Summary

Leflunomide is used alone or in combination with other medications to treat rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function). Leflunomide is in a class of medications called disease-modifying antirheumatic drugs (DMARDs). It works by decreasing inflammation and slowing the progress of the condition, which can help improve the physical activity of people with rheumatoid arthritis.

Related Packages: 70710-1158-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Leflunomide

Product Information

NDC	70710-1158
Product ID	70710-1158_b9ae0559-441f-4be3-88e5-336b2bbfa2b2
Associated GPIs	66280050000320
GCN Sequence Number	040550
GCN Sequence Number Description	leflunomide TABLET 20 MG ORAL
HIC3	S2I
HIC3 Description	ANTI-INFLAMMATORY, PYRIMIDINE SYNTHESIS INHIBITOR
GCN	67032
HICL Sequence Number	018694
HICL Sequence Number Description	LEFLUNOMIDE
Brand/Generic	Generic
Proprietary Name	leflunomide
Proprietary Name Suffix	n/a
Non-Proprietary Name	leflunomide
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	20
Active Ingredient Units	mg/1
Substance Name	LEFLUNOMIDE
Labeler Name	Zydus Pharmaceuticals (USA) Inc.
Pharmaceutical Class	Antirheumatic Agent [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA212308
Listing Certified Through	2024-12-31

Package

NDC 70710-1158-01 (70710115801)

Pricing Information	N/A
NDC Package Code	70710-1158-1
Billing NDC	70710115801
Package	100 TABLET, FILM COATED in 1 BOTTLE (70710-1158-1)
Marketing Start Date	2019-04-26
NDC Exclude Flag	N