NDC 46708-436

Leflunomide

Leflunomide

Leflunomide is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Leflunomide.

Product ID46708-436_e61a8fad-d513-4d27-aba0-e1a55b49c164
NDC46708-436
Product TypeHuman Prescription Drug
Proprietary NameLeflunomide
Generic NameLeflunomide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA091369
Labeler NameAlembic Pharmaceuticals Limited
Substance NameLEFLUNOMIDE
Active Ingredient Strength10 mg/1
Pharm ClassesAntirheumatic Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 46708-436-30

30 TABLET in 1 BOTTLE (46708-436-30)
Marketing Start Date2016-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-436-30 [46708043630]

Leflunomide TABLET
Marketing CategoryANDA
Application NumberANDA091369
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-01

NDC 46708-436-60 [46708043660]

Leflunomide TABLET
Marketing CategoryANDA
Application NumberANDA091369
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-01

NDC 46708-436-31 [46708043631]

Leflunomide TABLET
Marketing CategoryANDA
Application NumberANDA091369
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-01

NDC 46708-436-71 [46708043671]

Leflunomide TABLET
Marketing CategoryANDA
Application NumberANDA091369
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-01

Drug Details

Active Ingredients

IngredientStrength
LEFLUNOMIDE10 mg/1

OpenFDA Data

SPL SET ID:f6a4107e-b393-45ed-8e5a-70af5bd53826
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205285
  • 205284
  • UPC Code
  • 0346708437305
  • 0346708436308
  • 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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