afinitor disperz (0078-0627)

Drug Facts

Product Profile

Brand Name afinitor disperz

Generic Name everolimus

Labeler novartis pharmaceuticals corporation

Dosage Form TABLET, FOR SUSPENSION

Routes

ORAL

Active Ingredients

everolimus 3 mg/1

Manufacturer

Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0627

Product ID 0078-0627_79d3253f-e1e3-428f-8dd4-4f2fe76faa15

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category NDA

Application Number NDA203985

Listing Expiration 2027-12-31

Marketing Start 2012-08-29

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 00780627

Hyphenated Format 0078-0627

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 disperz (source: ndc)

Generic Name everolimus (source: ndc)

Application Number NDA203985 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

3 mg/1

source: ndc

Packaging

28 BLISTER PACK in 1 CARTON (0078-0627-51) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0627-61)

source: ndc

Packages (1)

0078-0627-51 28 BLISTER PACK in 1 CARTON (0078-0627-51) / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0627-61)

Ingredients (1)

everolimus (3 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 (0078-0627-51)  / 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0627-61)", "package_ndc": "0078-0627-51", "marketing_start_date": "20120829"}], "brand_name": "Afinitor Disperz", "product_id": "0078-0627_79d3253f-e1e3-428f-8dd4-4f2fe76faa15", "dosage_form": "TABLET, FOR SUSPENSION", "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": "0078-0627", "generic_name": "everolimus", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Afinitor", "brand_name_suffix": "Disperz", "active_ingredients": [{"name": "EVEROLIMUS", "strength": "3 mg/1"}], "application_number": "NDA203985", "marketing_category": "NDA", "marketing_start_date": "20120829", "listing_expiration_date": "20271231"}