NDC 42291-421

LEFLUNOMIDE

Leflunomide

LEFLUNOMIDE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Avkare, Inc. The primary component is Leflunomide.

Product ID42291-421_8b35eae9-5a56-1566-e053-2995a90aaba5
NDC42291-421
Product TypeHuman Prescription Drug
Proprietary NameLEFLUNOMIDE
Generic NameLeflunomide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-06-13
Marketing CategoryANDA / ANDA
Application NumberANDA077090
Labeler NameAvKARE, Inc
Substance NameLEFLUNOMIDE
Active Ingredient Strength20 mg/1
Pharm ClassesAntirheumatic Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42291-421-30

30 TABLET in 1 BOTTLE (42291-421-30)
Marketing Start Date2019-06-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-421-30 [42291042130]

LEFLUNOMIDE TABLET
Marketing CategoryANDA
Application NumberANDA077090
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-13

Drug Details

Active Ingredients

IngredientStrength
LEFLUNOMIDE20 mg/1

OpenFDA Data

SPL SET ID:8b365514-c859-ff93-e053-2a95a90ac698
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205285
  • 205284
  • Pharmacological Class

    • Antirheumatic Agent [EPC]

    NDC Crossover Matching brand name "LEFLUNOMIDE" or generic name "Leflunomide"

    NDCBrand NameGeneric Name
    0955-1735Leflunomideleflunomide
    0955-1737Leflunomideleflunomide
    10702-277LeflunomideLeflunomide
    10702-278LeflunomideLeflunomide
    13811-677LeflunomideLeflunomide
    13811-678LeflunomideLeflunomide
    23155-043LeflunomideLeflunomide
    68258-2992LeflunomideLeflunomide
    23155-044LeflunomideLeflunomide
    46708-437LeflunomideLeflunomide
    46708-436LeflunomideLeflunomide
    60505-2503LEFLUNOMIDELEFLUNOMIDE
    60505-2502LEFLUNOMIDELEFLUNOMIDE
    62332-062LeflunomideLeflunomide
    62332-061LeflunomideLeflunomide
    70710-1157leflunomideleflunomide
    70710-1158leflunomideleflunomide
    70771-1492leflunomideleflunomide
    70771-1491leflunomideleflunomide
    42291-420LEFLUNOMIDELEFLUNOMIDE
    42291-421LEFLUNOMIDELEFLUNOMIDE
    70748-130LeflunomideLeflunomide
    70748-129LeflunomideLeflunomide
    50268-477LEFLUNOMIDELEFLUNOMIDE
    50268-478LEFLUNOMIDELEFLUNOMIDE
    0088-2160Aravaleflunomide
    0088-2161Aravaleflunomide
    0088-2162Aravaleflunomide

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