everolimus

Generic: everolimus

Labeler: natco pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name everolimus
Generic Name everolimus
Labeler natco pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

everolimus 5 mg/1

Manufacturer
Natco Pharma Limited

Identifiers & Regulatory

Product NDC 63850-0059
Product ID 63850-0059_6df3819e-2d45-4030-a4af-6caeccb8a471
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205426
Listing Expiration 2026-12-31
Marketing Start 2021-03-05

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 638500059
Hyphenated Format 63850-0059

Supplemental Identifiers

RxCUI
845507 845515 998189 1119400
UPC
0363850006128 0363850005817 0363850006111 0363850005923 0363850005824 0363850005916 0363850006012
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 everolimus (source: ndc)
Generic Name everolimus (source: ndc)
Application Number ANDA205426 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (63850-0059-1) / 7 TABLET in 1 BLISTER PACK
  • 30 TABLET in 1 BOTTLE (63850-0059-4)
source: ndc

Packages (2)

63850-0059-1 4 BLISTER PACK in 1 CARTON (63850-0059-1) / 7 TABLET in 1 BLISTER PACK 63850-0059-4 30 TABLET in 1 BOTTLE (63850-0059-4)

Ingredients (1)

everolimus (5 mg/1)

Linked Drug Pages (1)

Everolimus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6df3819e-2d45-4030-a4af-6caeccb8a471", "openfda": {"nui": ["N0000175605", "N0000175076", "N0000182141", "N0000182137", "N0000175625", "N0000175624", "N0000175550"], "upc": ["0363850006128", "0363850005817", "0363850006111", "0363850005923", "0363850005824", "0363850005916", "0363850006012"], "unii": ["9HW64Q8G6G"], "rxcui": ["845507", "845515", "998189", "1119400"], "spl_set_id": ["e3dbbc24-7e55-4069-a305-e2cded2db641"], "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": ["Natco Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (63850-0059-1)  / 7 TABLET in 1 BLISTER PACK", "package_ndc": "63850-0059-1", "marketing_start_date": "20210305"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (63850-0059-4)", "package_ndc": "63850-0059-4", "marketing_start_date": "20230526"}], "brand_name": "Everolimus", "product_id": "63850-0059_6df3819e-2d45-4030-a4af-6caeccb8a471", "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": "63850-0059", "generic_name": "Everolimus", "labeler_name": "Natco Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Everolimus", "active_ingredients": [{"name": "EVEROLIMUS", "strength": "5 mg/1"}], "application_number": "ANDA205426", "marketing_category": "ANDA", "marketing_start_date": "20210305", "listing_expiration_date": "20261231"}