afinitor

Generic: everolimus

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name afinitor
Generic Name everolimus
Labeler novartis pharmaceuticals corporation
Dosage Form TABLET
Routes
ORAL
Active Ingredients

everolimus 5 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0566
Product ID 0078-0566_79d3253f-e1e3-428f-8dd4-4f2fe76faa15
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022334
Listing Expiration 2027-12-31
Marketing Start 2009-03-31

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc] mtor inhibitor immunosuppressant [epc]
Mechanism of Action
protein kinase inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] mtor inhibitors [moa]
Physiologic Effect
decreased immunologic activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780566
Hyphenated Format 0078-0566

Supplemental Identifiers

RxCUI
845507 845512 845515 845518 998189 998191 1119400 1119402 1308428 1308430 1308432 1310138 1310144 1310147
UNII
9HW64Q8G6G
NUI
N0000175605 N0000175076 N0000182141 N0000182137 N0000175625 N0000175624 N0000175550

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 afinitor (source: ndc)
Generic Name everolimus (source: ndc)
Application Number NDA022334 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 28 BLISTER PACK in 1 CARTON (0078-0566-51) / 1 TABLET in 1 BLISTER PACK (0078-0566-61)
source: ndc

Packages (1)

0078-0566-51 28 BLISTER PACK in 1 CARTON (0078-0566-51) / 1 TABLET in 1 BLISTER PACK (0078-0566-61)

Ingredients (1)

everolimus (5 mg/1)

Linked Drug Pages (1)

Afinitor, Afinitor Disperz ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "79d3253f-e1e3-428f-8dd4-4f2fe76faa15", "openfda": {"nui": ["N0000175605", "N0000175076", "N0000182141", "N0000182137", "N0000175625", "N0000175624", "N0000175550"], "unii": ["9HW64Q8G6G"], "rxcui": ["845507", "845512", "845515", "845518", "998189", "998191", "1119400", "1119402", "1308428", "1308430", "1308432", "1310138", "1310144", "1310147"], "spl_set_id": ["2150f73a-179b-4afc-b8ce-67c85cc72f04"], "pharm_class_pe": ["Decreased Immunologic Activity [PE]"], "pharm_class_epc": ["Kinase Inhibitor [EPC]", "mTOR Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Protein Kinase Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "mTOR Inhibitors [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 BLISTER PACK in 1 CARTON (0078-0566-51)  / 1 TABLET in 1 BLISTER PACK (0078-0566-61)", "package_ndc": "0078-0566-51", "marketing_start_date": "20090331"}], "brand_name": "Afinitor", "product_id": "0078-0566_79d3253f-e1e3-428f-8dd4-4f2fe76faa15", "dosage_form": "TABLET", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Decreased Immunologic Activity [PE]", "Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]", "mTOR Inhibitor Immunosuppressant [EPC]", "mTOR Inhibitors [MoA]"], "product_ndc": "0078-0566", "generic_name": "everolimus", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Afinitor", "active_ingredients": [{"name": "EVEROLIMUS", "strength": "5 mg/1"}], "application_number": "NDA022334", "marketing_category": "NDA", "marketing_start_date": "20090331", "listing_expiration_date": "20271231"}