NDC 0088-2162

Arava

Leflunomide

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

• Product ID: 0088-2162_04c7b15c-5ad7-4f56-a94f-70fde67d843f
• NDC: 0088-2162
• Product Type: Human Prescription Drug
• Proprietary Name: Arava
• Generic Name: Leflunomide
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 1998-09-19
• Marketing Category: NDA / NDA
• Application Number: NDA020905
• Labeler Name: sanofi-aventis U.S. LLC
• Substance Name: LEFLUNOMIDE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Antirheumatic Agent [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0088-2162-33

1 BLISTER PACK in 1 CARTON (0088-2162-33) > 3 TABLET, FILM COATED in 1 BLISTER PACK

• Marketing Start Date: 1998-09-19
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 0088-2162-33 [00088216233]

Arava TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020905
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1998-09-19

NDC 0088-2162-03 [00088216203]

Arava TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020905
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1998-09-19
• Marketing End Date: 2010-09-23

Drug Details

Active Ingredients

Ingredient	Strength
LEFLUNOMIDE	100 mg/1

OpenFDA Data

• SPL SET ID: 320f63f2-fac3-4aee-aff8-85724e00ef52
• Manufacturer:
  • sanofi-aventis U.S. LLC
• UNII:
  • G162GK9U4W
• RxNorm Concept Unique ID - RxCUI:
  • 213379
  • 213380
  • 213377
  • 205285
  • 205284
  • 205286

Pharmacological Class

• Antirheumatic Agent [EPC]

NDC Crossover Matching brand name "Arava" or generic name "Leflunomide"

NDC	Brand Name	Generic Name
0088-2160	Arava	leflunomide
0088-2161	Arava	leflunomide
0088-2162	Arava	leflunomide
0955-1735	Leflunomide	leflunomide
0955-1737	Leflunomide	leflunomide
10702-277	Leflunomide	Leflunomide
10702-278	Leflunomide	Leflunomide
13811-677	Leflunomide	Leflunomide
13811-678	Leflunomide	Leflunomide
23155-043	Leflunomide	Leflunomide