inlyta

Generic: axitinib

Labeler: u.s. pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name inlyta
Generic Name axitinib
Labeler u.s. pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

axitinib 5 mg/1

Manufacturer
U.S. Pharmaceuticals

Identifiers & Regulatory

Product NDC 63539-044
Product ID 63539-044_13bbdf50-7648-4e55-baf4-4eca79846978
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202324
Listing Expiration 2026-12-31
Marketing Start 2012-01-27

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
receptor tyrosine kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63539044
Hyphenated Format 63539-044

Supplemental Identifiers

RxCUI
1243004 1243010 1243012 1243014
UNII
C9LVQ0YUXG
NUI
N0000175605 N0000020000

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 inlyta (source: ndc)
Generic Name axitinib (source: ndc)
Application Number NDA202324 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (63539-044-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (63539-044-02)
source: ndc

Packages (2)

63539-044-01 60 TABLET, FILM COATED in 1 BOTTLE (63539-044-01) 63539-044-02 30 TABLET, FILM COATED in 1 BOTTLE (63539-044-02)

Ingredients (1)

axitinib (5 mg/1)

Linked Drug Pages (1)

INLYTA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "13bbdf50-7648-4e55-baf4-4eca79846978", "openfda": {"nui": ["N0000175605", "N0000020000"], "unii": ["C9LVQ0YUXG"], "rxcui": ["1243004", "1243010", "1243012", "1243014"], "spl_set_id": ["8a903e31-936e-4ed7-8a59-59f32374f338"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Receptor Tyrosine Kinase Inhibitors [MoA]"], "manufacturer_name": ["U.S. Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63539-044-01)", "package_ndc": "63539-044-01", "marketing_start_date": "20120127"}, {"sample": true, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63539-044-02)", "package_ndc": "63539-044-02", "marketing_start_date": "20120127"}], "brand_name": "INLYTA", "product_id": "63539-044_13bbdf50-7648-4e55-baf4-4eca79846978", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Receptor Tyrosine Kinase Inhibitors [MoA]"], "product_ndc": "63539-044", "generic_name": "axitinib", "labeler_name": "U.S. Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INLYTA", "active_ingredients": [{"name": "AXITINIB", "strength": "5 mg/1"}], "application_number": "NDA202324", "marketing_category": "NDA", "marketing_start_date": "20120127", "listing_expiration_date": "20261231"}