stivarga

Generic: regorafenib

Labeler: bayer healthcare pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name stivarga
Generic Name regorafenib
Labeler bayer healthcare pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

regorafenib 40 mg/1

Manufacturer
Bayer HealthCare Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 50419-171
Product ID 50419-171_8f47fb28-9855-4482-b807-e98c425c2a4e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203085
Listing Expiration 2027-12-31
Marketing Start 2012-09-27

Pharmacologic Class

Classes
breast cancer resistance protein inhibitors [moa] cytochrome p450 2c9 inhibitors [moa] kinase inhibitor [epc] kinase inhibitors [moa] ugt1a1 inhibitors [moa] ugt1a9 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50419171
Hyphenated Format 50419-171

Supplemental Identifiers

RxCUI
1312402 1312408
UNII
MGN125FS9D

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 stivarga (source: ndc)
Generic Name regorafenib (source: ndc)
Application Number NDA203085 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 210 BOTTLE in 1 BOX (50419-171-00) / 28 TABLET, FILM COATED in 1 BOTTLE
  • 3 BOTTLE, PLASTIC in 1 BOX (50419-171-03) / 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-01)
  • 1 BOTTLE, PLASTIC in 1 CARTON (50419-171-04) / 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 4 BOTTLE, PLASTIC in 1 CARTON (50419-171-06) / 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-05)
source: ndc

Packages (4)

50419-171-00 210 BOTTLE in 1 BOX (50419-171-00) / 28 TABLET, FILM COATED in 1 BOTTLE 50419-171-03 3 BOTTLE, PLASTIC in 1 BOX (50419-171-03) / 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-01) 50419-171-04 1 BOTTLE, PLASTIC in 1 CARTON (50419-171-04) / 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 50419-171-06 4 BOTTLE, PLASTIC in 1 CARTON (50419-171-06) / 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-05)

Ingredients (1)

regorafenib (40 mg/1)

Linked Drug Pages (1)

Stivarga ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8f47fb28-9855-4482-b807-e98c425c2a4e", "openfda": {"unii": ["MGN125FS9D"], "rxcui": ["1312402", "1312408"], "spl_set_id": ["824f19c9-0546-4a8a-8d8f-c4055c04f7c7"], "manufacturer_name": ["Bayer HealthCare Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "210 BOTTLE in 1 BOX (50419-171-00)  / 28 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "50419-171-00", "marketing_start_date": "20120927"}, {"sample": false, "description": "3 BOTTLE, PLASTIC in 1 BOX (50419-171-03)  / 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-01)", "package_ndc": "50419-171-03", "marketing_start_date": "20120927"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50419-171-04)  / 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "50419-171-04", "marketing_start_date": "20120927"}, {"sample": false, "description": "4 BOTTLE, PLASTIC in 1 CARTON (50419-171-06)  / 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-05)", "package_ndc": "50419-171-06", "marketing_start_date": "20210501"}], "brand_name": "Stivarga", "product_id": "50419-171_8f47fb28-9855-4482-b807-e98c425c2a4e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Kinase Inhibitor [EPC]", "Kinase Inhibitors [MoA]", "UGT1A1 Inhibitors [MoA]", "UGT1A9 Inhibitors [MoA]"], "product_ndc": "50419-171", "generic_name": "regorafenib", "labeler_name": "Bayer HealthCare Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Stivarga", "active_ingredients": [{"name": "REGORAFENIB", "strength": "40 mg/1"}], "application_number": "NDA203085", "marketing_category": "NDA", "marketing_start_date": "20120927", "listing_expiration_date": "20271231"}