NDC 70748-129

Leflunomide

Leflunomide

Leflunomide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals, Inc.. The primary component is Leflunomide.

Product ID70748-129_94bf71d8-81f1-4285-b2c0-364434bccc26
NDC70748-129
Product TypeHuman Prescription Drug
Proprietary NameLeflunomide
Generic NameLeflunomide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA211863
Labeler NameLupin Pharmaceuticals, Inc.
Substance NameLEFLUNOMIDE
Active Ingredient Strength10 mg/1
Pharm ClassesAntirheumatic Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70748-129-06

1 BOTTLE in 1 CARTON (70748-129-06) > 30 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2020-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70748-129-06 [70748012906]

Leflunomide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA211863
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-24

Drug Details

Active Ingredients

IngredientStrength
LEFLUNOMIDE10 mg/1

OpenFDA Data

SPL SET ID:5d48fded-b43b-461a-8488-ca1da5c41a03
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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