NDC 13811-678

Leflunomide

Leflunomide

Leflunomide is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Trigen Laboratories, Llc. The primary component is Leflunomide.

Product ID13811-678_90bcf9c0-f3ca-4634-a6f7-d24f134aaa14
NDC13811-678
Product TypeHuman Prescription Drug
Proprietary NameLeflunomide
Generic NameLeflunomide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-05-06
Marketing CategoryANDA / ANDA
Application NumberANDA091369
Labeler NameTrigen Laboratories, LLC
Substance NameLEFLUNOMIDE
Active Ingredient Strength20 mg/1
Pharm ClassesAntirheumatic Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 13811-678-30

30 TABLET in 1 BOTTLE (13811-678-30)
Marketing Start Date2011-05-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13811-678-50 [13811067850]

Leflunomide TABLET
Marketing CategoryANDA
Application NumberANDA091369
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-06
Marketing End Date2019-12-31

NDC 13811-678-30 [13811067830]

Leflunomide TABLET
Marketing CategoryANDA
Application NumberANDA091369
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-05-06
Marketing End Date2019-12-31

NDC 13811-678-60 [13811067860]

Leflunomide TABLET
Marketing CategoryANDA
Application NumberANDA091369
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-06
Marketing End Date2019-12-31

NDC 13811-678-10 [13811067810]

Leflunomide TABLET
Marketing CategoryANDA
Application NumberANDA091369
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-06
Marketing End Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
LEFLUNOMIDE20 mg/1

OpenFDA Data

SPL SET ID:332aeb48-8a1a-4d50-be12-05411b7a2967
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205285
  • 205284
    • UPC Code
  • 0313811677300
  • 0313811678307

    • Pharmacological Class

    • Antirheumatic Agent [EPC]

    Medicade Reported Pricing

    13811067830 LEFLUNOMIDE 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    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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