FDA.reportPublic FDA data

LEFLUNOMIDE

Product NDC
60505-2502
11-digit product format
605052502
Labeler code
60505
Product ID
60505-2502_ebee26d4-bf2a-e0eb-b0f4-e1212d0bed03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEFLUNOMIDE
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA077090
Marketing category
ANDA
Marketing start
2005-09-13
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
IngredientStrength
LEFLUNOMIDE10 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-2502-1LEFLUNOMIDE30 in 1 BOTTLETABLET3012
60505-2502-2LEFLUNOMIDE100 in 1 BOTTLETABLET10012
60505-2502-3LEFLUNOMIDE1000 in 1 BOTTLETABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2502-1EA - Each60505-2502e870b19b-e9cf-43c3-b5b5-f9f93490372a12012-07-24
60505-2502-3EA - Each60505-25022411286d-0f5a-4605-9e21-346dba50959612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEFLUNOMIDEACTIVE INGREDIENTG162GK9U4WLEFLUNOMIDE TABLET [APOTEX CORP. ]4
LEFLUNOMIDEACTIVE MOIETYG162GK9U4WLEFLUNOMIDE TABLET [APOTEX CORP. ]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKLEFLUNOMIDE TABLET [APOTEX CORP. ]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEFLUNOMIDE TABLET [APOTEX CORP. ]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEFLUNOMIDE TABLET [APOTEX CORP. ]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEFLUNOMIDE TABLET [APOTEX CORP. ]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2502LEFLUNOMIDE TABLET [APOTEX CORP. ]11Current NDC, Legacy NDC, 3 package rows20241025_753453c5-8a7a-878e-3ce7-1d1edce718a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205284leflunomide 10 MG Oral TabletPSN753453c5-8a7a-878e-3ce7-1d1edce718a912
205285leflunomide 20 MG Oral TabletPSN753453c5-8a7a-878e-3ce7-1d1edce718a912
205284leflunomide 10 MG Oral TabletSCD753453c5-8a7a-878e-3ce7-1d1edce718a912
205285leflunomide 20 MG Oral TabletSCD753453c5-8a7a-878e-3ce7-1d1edce718a912
205284leflunomide 10 MG Oral TabletPSN8b365514-c859-ff93-e053-2a95a90ac6985
205285leflunomide 20 MG Oral TabletPSN8b365514-c859-ff93-e053-2a95a90ac6985
205284leflunomide 10 MG Oral TabletSCD8b365514-c859-ff93-e053-2a95a90ac6985
205285leflunomide 20 MG Oral TabletSCD8b365514-c859-ff93-e053-2a95a90ac6985
205284leflunomide 10 MG Oral TabletPSNaf836cd0-da42-772e-e053-2995a90ac1034
205285leflunomide 20 MG Oral TabletPSNaf836cd0-da42-772e-e053-2995a90ac1034
205284leflunomide 10 MG Oral TabletSCDaf836cd0-da42-772e-e053-2995a90ac1034
205285leflunomide 20 MG Oral TabletSCDaf836cd0-da42-772e-e053-2995a90ac1034

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-2502-16050525020130 TABLET in 1 BOTTLE (60505-2502-1) 30 tablet2005-09-130000-00-00NoNoCurrent
60505-2502-260505250202100 TABLET in 1 BOTTLE (60505-2502-2) 100 tablet2005-09-130000-00-00NoNoCurrent
60505-2502-3605052502031000 TABLET in 1 BOTTLE (60505-2502-3) 1000 tablet2005-09-130000-00-00NoNoCurrent