evkeeza

Generic: evinacumab

Labeler: regeneron pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name evkeeza
Generic Name evinacumab
Labeler regeneron pharmaceuticals, inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

evinacumab 150 mg/mL

Manufacturer
Regeneron Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 61755-013
Product ID 61755-013_d95d8409-4a39-4b82-954d-e055409fa892
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761181
Listing Expiration 2026-12-31
Marketing Start 2021-02-11

Pharmacologic Class

Established (EPC)
angiopoietin-like 3 inhibitor [epc]
Mechanism of Action
angiopoietin-like 3 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61755013
Hyphenated Format 61755-013

Supplemental Identifiers

RxCUI
2478648 2478650 2478731 2478732
UNII
T8B2ORP1DW
NUI
N0000193915 N0000193916

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 evkeeza (source: ndc)
Generic Name evinacumab (source: ndc)
Application Number BLA761181 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 150 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (61755-013-01) / 2.3 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

61755-013-01 1 VIAL, SINGLE-USE in 1 CARTON (61755-013-01) / 2.3 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

evinacumab (150 mg/mL)

Linked Drug Pages (1)

Evkeeza ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "d95d8409-4a39-4b82-954d-e055409fa892", "openfda": {"nui": ["N0000193915", "N0000193916"], "unii": ["T8B2ORP1DW"], "rxcui": ["2478648", "2478650", "2478731", "2478732"], "spl_set_id": ["73412138-6d8f-4ea6-bb72-a740190470ff"], "pharm_class_epc": ["Angiopoietin-like 3 Inhibitor [EPC]"], "pharm_class_moa": ["Angiopoietin-like 3 Inhibitors [MoA]"], "manufacturer_name": ["Regeneron Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (61755-013-01)  / 2.3 mL in 1 VIAL, SINGLE-USE", "package_ndc": "61755-013-01", "marketing_start_date": "20210211"}], "brand_name": "Evkeeza", "product_id": "61755-013_d95d8409-4a39-4b82-954d-e055409fa892", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Angiopoietin-like 3 Inhibitor [EPC]", "Angiopoietin-like 3 Inhibitors [MoA]"], "product_ndc": "61755-013", "generic_name": "evinacumab", "labeler_name": "Regeneron Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Evkeeza", "active_ingredients": [{"name": "EVINACUMAB", "strength": "150 mg/mL"}], "application_number": "BLA761181", "marketing_category": "BLA", "marketing_start_date": "20210211", "listing_expiration_date": "20261231"}