sutent

Generic: sunitinib malate

Labeler: u.s. pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sutent
Generic Name sunitinib malate
Labeler u.s. pharmaceuticals
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

sunitinib malate 12.5 mg/1

Manufacturer
U.S. Pharmaceuticals

Identifiers & Regulatory

Product NDC 63539-017
Product ID 63539-017_21cadbc0-3f0e-4789-80ee-bf1e3982d85f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021938
Listing Expiration 2026-12-31
Marketing Start 2006-01-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63539017
Hyphenated Format 63539-017

Supplemental Identifiers

RxCUI
616279 616283 616289 616292
UNII
LVX8N1UT73

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 sutent (source: ndc)
Generic Name sunitinib malate (source: ndc)
Application Number NDA021938 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 28 CAPSULE in 1 BOTTLE (63539-017-01)
source: ndc

Packages (1)

63539-017-01 28 CAPSULE in 1 BOTTLE (63539-017-01)

Ingredients (1)

sunitinib malate (12.5 mg/1)

Linked Drug Pages (1)

SUTENT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21cadbc0-3f0e-4789-80ee-bf1e3982d85f", "openfda": {"unii": ["LVX8N1UT73"], "rxcui": ["616279", "616283", "616289", "616292"], "spl_set_id": ["a5d555f5-d66a-4f94-abcf-96fa6d71a32f"], "manufacturer_name": ["U.S. Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "28 CAPSULE in 1 BOTTLE (63539-017-01)", "package_ndc": "63539-017-01", "marketing_start_date": "20180605"}], "brand_name": "SUTENT", "product_id": "63539-017_21cadbc0-3f0e-4789-80ee-bf1e3982d85f", "dosage_form": "CAPSULE", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "63539-017", "generic_name": "Sunitinib malate", "labeler_name": "U.S. Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SUTENT", "active_ingredients": [{"name": "SUNITINIB MALATE", "strength": "12.5 mg/1"}], "application_number": "NDA021938", "marketing_category": "NDA", "marketing_start_date": "20060126", "listing_expiration_date": "20261231"}