NDC 0597-0143

Ofev

Nintedanib

Ofev is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Nintedanib Esylate.

• Product ID: 0597-0143_4ba117f7-c939-416a-b033-03d288a28652
• NDC: 0597-0143
• Product Type: Human Prescription Drug
• Proprietary Name: Ofev
• Generic Name: Nintedanib
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2014-10-15
• Marketing Category: NDA / NDA
• Application Number: NDA205832
• Labeler Name: Boehringer Ingelheim Pharmaceuticals, Inc.
• Substance Name: NINTEDANIB ESYLATE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0597-0143-60

1 BOTTLE in 1 CARTON (0597-0143-60) > 60 CAPSULE in 1 BOTTLE

• Marketing Start Date: 2014-10-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0597-0143-60 [00597014360]

Ofev CAPSULE

• Marketing Category: NDA
• Application Number: NDA205832
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-10-17

Drug Details

Active Ingredients

Ingredient	Strength
NINTEDANIB ESYLATE	100 mg/1

OpenFDA Data

• SPL SET ID: da1c9f37-779e-4682-816f-93d0faa4cfc9
• Manufacturer:
  • Boehringer Ingelheim Pharmaceuticals, Inc.
• UNII:
  • 42F62RTZ4G
• RxNorm Concept Unique ID - RxCUI:
  • 1592752
  • 1592750
  • 1592748
  • 1592742

Pharmacological Class

• Kinase Inhibitor [EPC]
• Protein Kinase Inhibitors [MoA]

NDC Crossover Matching brand name "Ofev" or generic name "Nintedanib"

NDC	Brand Name	Generic Name
0597-0143	Ofev	nintedanib
0597-0145	Ofev	nintedanib