NDC 0955-1737

Leflunomide

Leflunomide

Leflunomide is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Winthrop U.s.. The primary component is Leflunomide.

Product ID0955-1737_1a310ca6-3c14-44dd-975a-3da704a7fd67
NDC0955-1737
Product TypeHuman Prescription Drug
Proprietary NameLeflunomide
Generic NameLeflunomide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-09-07
Marketing CategoryNDA / NDA
Application NumberNDA020905
Labeler NameWinthrop U.S.
Substance NameLEFLUNOMIDE
Active Ingredient Strength20 mg/1
Pharm ClassesAntirheumatic Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0955-1737-30

1 BOTTLE in 1 CARTON (0955-1737-30) > 30 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2015-09-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0955-1737-30 [00955173730]

Leflunomide TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020905
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-09-07

Drug Details

Active Ingredients

IngredientStrength
LEFLUNOMIDE20 mg/1

OpenFDA Data

SPL SET ID:eb85de02-2964-453b-978a-26451cd1c97a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205285
  • 205284
  • Pharmacological Class

    • Antirheumatic Agent [EPC]
    • 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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