FDA.reportPublic FDA data

Leflunomide

Product NDC
10702-278
11-digit product format
107020278
Labeler code
10702
Product ID
10702-278_3843c448-c1bf-a403-e063-6394a90a3e77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Leflunomide
Dosage form
TABLET
Route
ORAL
Labeler
KVK-Tech, Inc.
Application
ANDA212453
Marketing category
ANDA
Marketing start
2020-07-23
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
IngredientStrength
LEFLUNOMIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG162GK9U4W
Rxcui205284, 205285

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10702-278-032024-05-01C16284748780-11030e365-5569-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS. Leflunomide Tablets, for oral use Initial U.S. Approval: 1998
10702-278-032024-01-30C16284748780-11030e365-5569-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LEFLUNOMIDE TABLETS safely and effectively. See full prescribing information for LEFLUNOMIDE TABLETS. Leflunomide Tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10702-278-03Leflunomide30 in 1 BOTTLETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-278-03EA - Each10702-2784216bcda-a332-4d8a-9a37-b214708da2fd12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-278LEFLUNOMIDE TABLET [KVK-TECH, INC.]5Current NDC, Legacy NDC, 1 package rows20240502_a48e6ef2-48ad-4fcf-9e67-dbba83ab0b79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205284leflunomide 10 MG Oral TabletPSNa48e6ef2-48ad-4fcf-9e67-dbba83ab0b796
205285leflunomide 20 MG Oral TabletPSNa48e6ef2-48ad-4fcf-9e67-dbba83ab0b796
205284leflunomide 10 MG Oral TabletSCDa48e6ef2-48ad-4fcf-9e67-dbba83ab0b796
205285leflunomide 20 MG Oral TabletSCDa48e6ef2-48ad-4fcf-9e67-dbba83ab0b796

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-278-031070202780330 TABLET in 1 BOTTLE (10702-278-03) 30 tablet2020-07-230000-00-00NoNoCurrent