everolimus

Generic: everolimus tablets

Labeler: breckenridge pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name everolimus
Generic Name everolimus tablets
Labeler breckenridge pharmaceutical, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

everolimus .5 mg/1

Manufacturer
Breckenridge Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 51991-380
Product ID 51991-380_e7f5ef4d-6763-4908-9b64-c2a2f600b2c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205432
Listing Expiration 2026-12-31
Marketing Start 2021-05-21

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 51991380
Hyphenated Format 51991-380

Supplemental Identifiers

RxCUI
977427 977434 977438 2056895
UPC
0351991985068 0351991379997 0351991380061 0351991379065 0351991380993 0351991381990 0351991381068
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 tablets (source: ndc)
Application Number ANDA205432 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (51991-380-06)
  • 60 BLISTER PACK in 1 CARTON (51991-380-60) / 10 TABLET in 1 BLISTER PACK (51991-380-99)
source: ndc

Packages (2)

51991-380-06 60 TABLET in 1 BOTTLE (51991-380-06) 51991-380-60 60 BLISTER PACK in 1 CARTON (51991-380-60) / 10 TABLET in 1 BLISTER PACK (51991-380-99)

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": "e7f5ef4d-6763-4908-9b64-c2a2f600b2c8", "openfda": {"nui": ["N0000175605", "N0000175076", "N0000182141", "N0000182137", "N0000175625", "N0000175624", "N0000175550"], "upc": ["0351991985068", "0351991379997", "0351991380061", "0351991379065", "0351991380993", "0351991381990", "0351991381068"], "unii": ["9HW64Q8G6G"], "rxcui": ["977427", "977434", "977438", "2056895"], "spl_set_id": ["c7bb6ba1-9a7f-43f5-b058-ef26d4b59221"], "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": ["Breckenridge Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (51991-380-06)", "package_ndc": "51991-380-06", "marketing_start_date": "20230313"}, {"sample": false, "description": "60 BLISTER PACK in 1 CARTON (51991-380-60)  / 10 TABLET in 1 BLISTER PACK (51991-380-99)", "package_ndc": "51991-380-60", "marketing_start_date": "20210521"}], "brand_name": "Everolimus", "product_id": "51991-380_e7f5ef4d-6763-4908-9b64-c2a2f600b2c8", "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": "51991-380", "generic_name": "Everolimus tablets", "labeler_name": "Breckenridge Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Everolimus", "active_ingredients": [{"name": "EVEROLIMUS", "strength": ".5 mg/1"}], "application_number": "ANDA205432", "marketing_category": "ANDA", "marketing_start_date": "20210521", "listing_expiration_date": "20261231"}