sunitinib malate

Generic: sunitinib malate

Labeler: novugen pharma (usa) llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sunitinib malate
Generic Name sunitinib malate
Labeler novugen pharma (usa) llc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

sunitinib malate 12.5 mg/1

Manufacturer
Novugen Pharma (USA) LLC.

Identifiers & Regulatory

Product NDC 82293-014
Product ID 82293-014_21d0ff80-d937-abb3-e063-6394a90af4b7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218012
Listing Expiration 2026-12-31
Marketing Start 2024-05-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82293014
Hyphenated Format 82293-014

Supplemental Identifiers

RxCUI
616279 616285 616289 1541890
UPC
0382293017102 0382293015108
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 ANDA218012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 28 CAPSULE in 1 BOTTLE (82293-014-10)
source: ndc

Packages (1)

82293-014-10 28 CAPSULE in 1 BOTTLE (82293-014-10)

Ingredients (1)

sunitinib malate (12.5 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": "21d0ff80-d937-abb3-e063-6394a90af4b7", "openfda": {"upc": ["0382293017102", "0382293015108"], "unii": ["LVX8N1UT73"], "rxcui": ["616279", "616285", "616289", "1541890"], "spl_set_id": ["04d34bce-1296-d2b9-e063-6394a90a7018"], "manufacturer_name": ["Novugen Pharma (USA) LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 CAPSULE in 1 BOTTLE (82293-014-10)", "package_ndc": "82293-014-10", "marketing_start_date": "20240501"}], "brand_name": "Sunitinib Malate", "product_id": "82293-014_21d0ff80-d937-abb3-e063-6394a90af4b7", "dosage_form": "CAPSULE", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "82293-014", "generic_name": "Sunitinib Malate", "labeler_name": "Novugen Pharma (USA) LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sunitinib Malate", "active_ingredients": [{"name": "SUNITINIB MALATE", "strength": "12.5 mg/1"}], "application_number": "ANDA218012", "marketing_category": "ANDA", "marketing_start_date": "20240501", "listing_expiration_date": "20261231"}