everolimus

Generic: everolimus

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

Drug Facts

Product Profile

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

everolimus 5 mg/1

Manufacturer
Breckenridge Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 51991-822
Product ID 51991-822_fade73fb-a367-4c53-83dd-1352c3ad807b
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 51991822
Hyphenated Format 51991-822

Supplemental Identifiers

RxCUI
845507 845515 998189 1119400 1308428 1308430 1308432
UPC
0351991822332 0351991823339 0351991824336 0351991821335
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 (51991-822-28) / 7 TABLET in 1 BLISTER PACK (51991-822-99)
  • 30 TABLET in 1 BOTTLE (51991-822-33)
source: ndc

Packages (2)

51991-822-28 4 BLISTER PACK in 1 CARTON (51991-822-28) / 7 TABLET in 1 BLISTER PACK (51991-822-99) 51991-822-33 30 TABLET in 1 BOTTLE (51991-822-33)

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": "fade73fb-a367-4c53-83dd-1352c3ad807b", "openfda": {"nui": ["N0000175605", "N0000175076", "N0000182141", "N0000182137", "N0000175625", "N0000175624", "N0000175550"], "upc": ["0351991822332", "0351991823339", "0351991824336", "0351991821335"], "unii": ["9HW64Q8G6G"], "rxcui": ["845507", "845515", "998189", "1119400", "1308428", "1308430", "1308432"], "spl_set_id": ["01f7b5fb-be0d-4adf-acd2-6899018de966"], "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": "4 BLISTER PACK in 1 CARTON (51991-822-28)  / 7 TABLET in 1 BLISTER PACK (51991-822-99)", "package_ndc": "51991-822-28", "marketing_start_date": "20210305"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (51991-822-33)", "package_ndc": "51991-822-33", "marketing_start_date": "20230605"}], "brand_name": "Everolimus", "product_id": "51991-822_fade73fb-a367-4c53-83dd-1352c3ad807b", "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": "51991-822", "generic_name": "Everolimus", "labeler_name": "Breckenridge Pharmaceutical, Inc.", "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"}