sunitinib malate

Generic: sunitinib malate

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sunitinib malate
Generic Name sunitinib malate
Labeler novadoz pharmaceuticals llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

sunitinib malate 25 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-117
Product ID 72205-117_15dd0555-b33f-4f56-94d3-0f4ce888df01
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214824
Listing Expiration 2026-12-31
Marketing Start 2025-02-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72205117
Hyphenated Format 72205-117

Supplemental Identifiers

RxCUI
616279 616285 616289 1541890
UPC
0372205118287 0372205116283 0372205119284 0372205117280
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 ANDA214824 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 28 CAPSULE in 1 BOTTLE (72205-117-28)
source: ndc

Packages (1)

72205-117-28 28 CAPSULE in 1 BOTTLE (72205-117-28)

Ingredients (1)

sunitinib malate (25 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": "15dd0555-b33f-4f56-94d3-0f4ce888df01", "openfda": {"upc": ["0372205118287", "0372205116283", "0372205119284", "0372205117280"], "unii": ["LVX8N1UT73"], "rxcui": ["616279", "616285", "616289", "1541890"], "spl_set_id": ["15dd0555-b33f-4f56-94d3-0f4ce888df01"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 CAPSULE in 1 BOTTLE (72205-117-28)", "package_ndc": "72205-117-28", "marketing_start_date": "20250601"}], "brand_name": "Sunitinib Malate", "product_id": "72205-117_15dd0555-b33f-4f56-94d3-0f4ce888df01", "dosage_form": "CAPSULE", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "72205-117", "generic_name": "Sunitinib Malate", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sunitinib Malate", "active_ingredients": [{"name": "SUNITINIB MALATE", "strength": "25 mg/1"}], "application_number": "ANDA214824", "marketing_category": "ANDA", "marketing_start_date": "20250214", "listing_expiration_date": "20261231"}