sunitinib malate

Generic: sunitinib malate

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sunitinib malate
Generic Name sunitinib malate
Labeler aurobindo pharma limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

sunitinib malate 50 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-467
Product ID 59651-467_a3d2b07e-f9d2-4f17-9a80-025d77ff8f7e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218615
Listing Expiration 2026-12-31
Marketing Start 2024-03-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651467
Hyphenated Format 59651-467

Supplemental Identifiers

RxCUI
616279 616285 616289 1541890
UPC
0359651466292 0359651465295 0359651467299
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 sunitinib malate (source: ndc)
Generic Name sunitinib malate (source: ndc)
Application Number ANDA218615 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 28 CAPSULE in 1 BOTTLE (59651-467-28)
  • 4 BLISTER PACK in 1 CARTON (59651-467-29) / 7 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (2)

59651-467-28 28 CAPSULE in 1 BOTTLE (59651-467-28) 59651-467-29 4 BLISTER PACK in 1 CARTON (59651-467-29) / 7 CAPSULE in 1 BLISTER PACK

Ingredients (1)

sunitinib malate (50 mg/1)

Linked Drug Pages (1)

SUNITINIB MALATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a3d2b07e-f9d2-4f17-9a80-025d77ff8f7e", "openfda": {"upc": ["0359651466292", "0359651465295", "0359651467299"], "unii": ["LVX8N1UT73"], "rxcui": ["616279", "616285", "616289", "1541890"], "spl_set_id": ["810dfcb2-d35b-4971-887c-2e78e82e9e07"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 CAPSULE in 1 BOTTLE (59651-467-28)", "package_ndc": "59651-467-28", "marketing_start_date": "20240314"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (59651-467-29)  / 7 CAPSULE in 1 BLISTER PACK", "package_ndc": "59651-467-29", "marketing_start_date": "20240314"}], "brand_name": "SUNITINIB MALATE", "product_id": "59651-467_a3d2b07e-f9d2-4f17-9a80-025d77ff8f7e", "dosage_form": "CAPSULE", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "59651-467", "generic_name": "SUNITINIB MALATE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SUNITINIB MALATE", "active_ingredients": [{"name": "SUNITINIB MALATE", "strength": "50 mg/1"}], "application_number": "ANDA218615", "marketing_category": "ANDA", "marketing_start_date": "20240314", "listing_expiration_date": "20261231"}