everolimus

Generic: everolimus

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

Drug Facts

Product Profile

Brand Name everolimus
Generic Name everolimus
Labeler hikma pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

everolimus 2.5 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-0480
Product ID 0054-0480_7558b1b9-ed53-4abc-8a08-194c945bb00f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207486
Listing Expiration 2026-12-31
Marketing Start 2020-06-08

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 00540480
Hyphenated Format 0054-0480

Supplemental Identifiers

RxCUI
845507 845515 998189 1119400
UPC
0300540480134 0300540497132 0300540481131 0300540482138
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 ANDA207486 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (0054-0480-13)
source: ndc

Packages (1)

0054-0480-13 30 TABLET in 1 BOTTLE (0054-0480-13)

Ingredients (1)

everolimus (2.5 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": "7558b1b9-ed53-4abc-8a08-194c945bb00f", "openfda": {"nui": ["N0000175605", "N0000175076", "N0000182141", "N0000182137", "N0000175625", "N0000175624", "N0000175550"], "upc": ["0300540480134", "0300540497132", "0300540481131", "0300540482138"], "unii": ["9HW64Q8G6G"], "rxcui": ["845507", "845515", "998189", "1119400"], "spl_set_id": ["5aaf2fb7-93f6-40d6-941a-9583a3794ce7"], "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": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (0054-0480-13)", "package_ndc": "0054-0480-13", "marketing_start_date": "20210212"}], "brand_name": "Everolimus", "product_id": "0054-0480_7558b1b9-ed53-4abc-8a08-194c945bb00f", "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": "0054-0480", "generic_name": "Everolimus", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Everolimus", "active_ingredients": [{"name": "EVEROLIMUS", "strength": "2.5 mg/1"}], "application_number": "ANDA207486", "marketing_category": "ANDA", "marketing_start_date": "20200608", "listing_expiration_date": "20261231"}