NDC 68258-2992

Leflunomide

Leflunomide

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

Product ID68258-2992_be0d579b-3b66-4227-b532-b0ee186a24ad
NDC68258-2992
Product TypeHuman Prescription Drug
Proprietary NameLeflunomide
Generic NameLeflunomide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2009-10-29
Marketing CategoryANDA / ANDA
Application NumberANDA077086
Labeler NameDispensing Solutions, Inc.
Substance NameLEFLUNOMIDE
Active Ingredient Strength20 mg/1
Pharm ClassesAntirheumatic Agent [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68258-2992-3

30 TABLET in 1 BOTTLE (68258-2992-3)
Marketing Start Date2009-10-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68258-2992-3 [68258299203]

Leflunomide TABLET
Marketing CategoryANDA
Application NumberANDA077086
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-10-29
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
LEFLUNOMIDE20 mg/1

OpenFDA Data

SPL SET ID:2fcef74c-2df9-4b16-b2f6-82c25957a680
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205285

    • 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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