sunitinib malate

Generic: sunitinib malate

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sunitinib malate
Generic Name sunitinib malate
Labeler teva pharmaceuticals usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

sunitinib malate 50 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-8231
Product ID 0093-8231_20ff6da6-32c4-421d-b7b0-604a502bfcb5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213803
Listing Expiration 2026-12-31
Marketing Start 2021-12-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00938231
Hyphenated Format 0093-8231

Supplemental Identifiers

RxCUI
616279 616285 616289 1541890
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 ANDA213803 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 28 CAPSULE in 1 BOTTLE (0093-8231-28)
source: ndc

Packages (1)

0093-8231-28 28 CAPSULE in 1 BOTTLE (0093-8231-28)

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": "20ff6da6-32c4-421d-b7b0-604a502bfcb5", "openfda": {"unii": ["LVX8N1UT73"], "rxcui": ["616279", "616285", "616289", "1541890"], "spl_set_id": ["a9479e5f-914f-46ca-95c1-327c66457e47"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 CAPSULE in 1 BOTTLE (0093-8231-28)", "package_ndc": "0093-8231-28", "marketing_start_date": "20211222"}], "brand_name": "Sunitinib Malate", "product_id": "0093-8231_20ff6da6-32c4-421d-b7b0-604a502bfcb5", "dosage_form": "CAPSULE", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "0093-8231", "generic_name": "Sunitinib Malate", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sunitinib Malate", "active_ingredients": [{"name": "SUNITINIB MALATE", "strength": "50 mg/1"}], "application_number": "ANDA213803", "marketing_category": "ANDA", "marketing_start_date": "20211222", "listing_expiration_date": "20261231"}