ofev

Generic: nintedanib

Labeler: boehringer ingelheim pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ofev
Generic Name nintedanib
Labeler boehringer ingelheim pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nintedanib esylate 150 mg/1

Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0597-0145
Product ID 0597-0145_5c860918-0d7e-4aaf-b103-85f66e9dcdbe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205832
Listing Expiration 2026-12-31
Marketing Start 2014-10-15

Pharmacologic Class

Classes
kinase inhibitor [epc] protein kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05970145
Hyphenated Format 0597-0145

Supplemental Identifiers

RxCUI
1592742 1592748 1592750 1592752
UNII
42F62RTZ4G

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name ofev (source: ndc)
Generic Name nintedanib (source: ndc)
Application Number NDA205832 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0597-0145-60) / 60 CAPSULE in 1 BOTTLE
source: ndc

Packages (1)

0597-0145-60 1 BOTTLE in 1 CARTON (0597-0145-60) / 60 CAPSULE in 1 BOTTLE

Ingredients (1)

nintedanib esylate (150 mg/1)

Linked Drug Pages (1)

Ofev ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5c860918-0d7e-4aaf-b103-85f66e9dcdbe", "openfda": {"unii": ["42F62RTZ4G"], "rxcui": ["1592742", "1592748", "1592750", "1592752"], "spl_set_id": ["da1c9f37-779e-4682-816f-93d0faa4cfc9"], "manufacturer_name": ["Boehringer Ingelheim Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0597-0145-60)  / 60 CAPSULE in 1 BOTTLE", "package_ndc": "0597-0145-60", "marketing_start_date": "20141017"}], "brand_name": "Ofev", "product_id": "0597-0145_5c860918-0d7e-4aaf-b103-85f66e9dcdbe", "dosage_form": "CAPSULE", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "0597-0145", "generic_name": "nintedanib", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ofev", "active_ingredients": [{"name": "NINTEDANIB ESYLATE", "strength": "150 mg/1"}], "application_number": "NDA205832", "marketing_category": "NDA", "marketing_start_date": "20141015", "listing_expiration_date": "20261231"}