everolimus

Generic: everolimus

Labeler: amneal pharmaceuticals ny llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name everolimus
Generic Name everolimus
Labeler amneal pharmaceuticals ny llc
Dosage Form TABLET, FOR SUSPENSION
Routes
ORAL
Active Ingredients

everolimus 5 mg/1

Manufacturer
Amneal Pharmaceuticals NY LLC

Identifiers & Regulatory

Product NDC 60219-2281
Product ID 60219-2281_1ae4c556-0dc0-4256-af5b-75b36ed76998
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218863
Listing Expiration 2026-12-31
Marketing Start 2025-01-14

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 602192281
Hyphenated Format 60219-2281

Supplemental Identifiers

RxCUI
1308428 1308430 1308432
UPC
0360219228115 0360219228016 0360219227910
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 ANDA218863 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (60219-2281-2) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK (60219-2281-1)
source: ndc

Packages (1)

60219-2281-2 4 BLISTER PACK in 1 CARTON (60219-2281-2) / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK (60219-2281-1)

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": "1ae4c556-0dc0-4256-af5b-75b36ed76998", "openfda": {"nui": ["N0000175605", "N0000175076", "N0000182141", "N0000182137", "N0000175625", "N0000175624", "N0000175550"], "upc": ["0360219228115", "0360219228016", "0360219227910"], "unii": ["9HW64Q8G6G"], "rxcui": ["1308428", "1308430", "1308432"], "spl_set_id": ["6f1ae129-c21e-4c25-84c1-a6757d9a7eb2"], "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": ["Amneal Pharmaceuticals NY LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (60219-2281-2)  / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK (60219-2281-1)", "package_ndc": "60219-2281-2", "marketing_start_date": "20250114"}], "brand_name": "EVEROLIMUS", "product_id": "60219-2281_1ae4c556-0dc0-4256-af5b-75b36ed76998", "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": "60219-2281", "generic_name": "everolimus", "labeler_name": "Amneal Pharmaceuticals NY LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EVEROLIMUS", "active_ingredients": [{"name": "EVEROLIMUS", "strength": "5 mg/1"}], "application_number": "ANDA218863", "marketing_category": "ANDA", "marketing_start_date": "20250114", "listing_expiration_date": "20261231"}