NDC 70710-1157

leflunomide

Leflunomide

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

Product ID70710-1157_c9906419-d11a-4520-9f2d-88b94e622fe5
NDC70710-1157
Product TypeHuman Prescription Drug
Proprietary Nameleflunomide
Generic NameLeflunomide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-04-26
Marketing CategoryANDA / ANDA
Application NumberANDA212308
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameLEFLUNOMIDE
Active Ingredient Strength10 mg/1
Pharm ClassesAntirheumatic Agent [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70710-1157-1

100 TABLET, FILM COATED in 1 BOTTLE (70710-1157-1)
Marketing Start Date2019-04-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70710-1157-3 [70710115703]

leflunomide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA212308
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-04-26

NDC 70710-1157-5 [70710115705]

leflunomide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA212308
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-26

NDC 70710-1157-1 [70710115701]

leflunomide TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA212308
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-26

Drug Details

Active Ingredients

IngredientStrength
LEFLUNOMIDE10 mg/1

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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