sunitinib malate

Generic: sunitinib malate

Labeler: sun pharmaceutical industries inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sunitinib malate
Generic Name sunitinib malate
Labeler sun pharmaceutical industries inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

sunitinib malate 12.5 mg/1

Manufacturer
Sun Pharmaceutical Industries Inc.

Identifiers & Regulatory

Product NDC 63304-091
Product ID 63304-091_2971c7ca-50dc-e36c-e063-6294a90a4b7d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213914
Listing Expiration 2026-12-31
Marketing Start 2019-12-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63304091
Hyphenated Format 63304-091

Supplemental Identifiers

RxCUI
616279 616285 616289 1541890
UPC
0363304092271
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 ANDA213914 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 28 CAPSULE in 1 BOTTLE (63304-091-27)
  • 4 BLISTER PACK in 1 BOX (63304-091-86) / 7 CAPSULE in 1 BLISTER PACK (63304-091-11)
source: ndc

Packages (2)

63304-091-27 28 CAPSULE in 1 BOTTLE (63304-091-27) 63304-091-86 4 BLISTER PACK in 1 BOX (63304-091-86) / 7 CAPSULE in 1 BLISTER PACK (63304-091-11)

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": "2971c7ca-50dc-e36c-e063-6294a90a4b7d", "openfda": {"upc": ["0363304092271"], "unii": ["LVX8N1UT73"], "rxcui": ["616279", "616285", "616289", "1541890"], "spl_set_id": ["06e0ad28-6637-4f54-879c-2c194aece5fd"], "manufacturer_name": ["Sun Pharmaceutical Industries Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 CAPSULE in 1 BOTTLE (63304-091-27)", "package_ndc": "63304-091-27", "marketing_start_date": "20191225"}, {"sample": false, "description": "4 BLISTER PACK in 1 BOX (63304-091-86)  / 7 CAPSULE in 1 BLISTER PACK (63304-091-11)", "package_ndc": "63304-091-86", "marketing_start_date": "20191225"}], "brand_name": "Sunitinib malate", "product_id": "63304-091_2971c7ca-50dc-e36c-e063-6294a90a4b7d", "dosage_form": "CAPSULE", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "63304-091", "generic_name": "Sunitinib malate", "labeler_name": "Sun Pharmaceutical Industries Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sunitinib malate", "active_ingredients": [{"name": "SUNITINIB MALATE", "strength": "12.5 mg/1"}], "application_number": "ANDA213914", "marketing_category": "ANDA", "marketing_start_date": "20191225", "listing_expiration_date": "20261231"}