NDC 10702-277

Leflunomide

Leflunomide

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

Product ID10702-277_0a1872eb-0524-4cd1-9cc0-3d81c262f4fd
NDC10702-277
Product TypeHuman Prescription Drug
Proprietary NameLeflunomide
Generic NameLeflunomide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-06-03
Marketing CategoryANDA / ANDA
Application NumberANDA212453
Labeler NameKVK-Tech, Inc.
Substance NameLEFLUNOMIDE
Active Ingredient Strength10 mg/1
Pharm ClassesAntirheumatic Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 10702-277-03

30 TABLET in 1 BOTTLE (10702-277-03)
Marketing Start Date2019-06-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10702-277-03 [10702027703]

Leflunomide TABLET
Marketing CategoryANDA
Application NumberANDA212453
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-03

Drug Details

Active Ingredients

IngredientStrength
LEFLUNOMIDE10 mg/1

OpenFDA Data

SPL SET ID:a48e6ef2-48ad-4fcf-9e67-dbba83ab0b79
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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.