sutent

Generic: sunitinib malate

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sutent
Generic Name sunitinib malate
Labeler pfizer laboratories div pfizer inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

sunitinib malate 37.5 mg/1

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-0830
Product ID 0069-0830_530eef58-b5ab-49f1-8d73-a2dae0356f24
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021938
Listing Expiration 2027-12-31
Marketing Start 2014-07-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00690830
Hyphenated Format 0069-0830

Supplemental Identifiers

RxCUI
616279 616283 616285 616287 616289 616292 1541890 1541928
UPC
0300690980386 0300690550381 0300690830384 0300690770383
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
  • 37.5 mg/1
source: ndc
Packaging
  • 28 CAPSULE in 1 BOTTLE (0069-0830-38)
source: ndc

Packages (1)

0069-0830-38 28 CAPSULE in 1 BOTTLE (0069-0830-38)

Ingredients (1)

sunitinib malate (37.5 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": "530eef58-b5ab-49f1-8d73-a2dae0356f24", "openfda": {"upc": ["0300690980386", "0300690550381", "0300690830384", "0300690770383"], "unii": ["LVX8N1UT73"], "rxcui": ["616279", "616283", "616285", "616287", "616289", "616292", "1541890", "1541928"], "spl_set_id": ["43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 CAPSULE in 1 BOTTLE (0069-0830-38)", "package_ndc": "0069-0830-38", "marketing_start_date": "20140712"}], "brand_name": "SUTENT", "product_id": "0069-0830_530eef58-b5ab-49f1-8d73-a2dae0356f24", "dosage_form": "CAPSULE", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "0069-0830", "generic_name": "Sunitinib malate", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SUTENT", "active_ingredients": [{"name": "SUNITINIB MALATE", "strength": "37.5 mg/1"}], "application_number": "NDA021938", "marketing_category": "NDA", "marketing_start_date": "20140712", "listing_expiration_date": "20271231"}