alhemo

Generic: concizumab

Labeler: novo nordisk
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name alhemo
Generic Name concizumab
Labeler novo nordisk
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

concizumab 40 mg/mL

Manufacturer
Novo Nordisk

Identifiers & Regulatory

Product NDC 0169-2084
Product ID 0169-2084_ff2589ac-650f-4740-984d-e950f785c1fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761315
Listing Expiration 2026-12-31
Marketing Start 2025-02-19

Pharmacologic Class

Established (EPC)
tissue factor pathway inhibitor antagonist [epc]
Mechanism of Action
tissue factor pathway inhibitor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01692084
Hyphenated Format 0169-2084

Supplemental Identifiers

RxCUI
2708346 2708353 2708356 2708359 2708361 2708362
UNII
68603V9EAF
NUI
N0000194160 N0000194161

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 alhemo (source: ndc)
Generic Name concizumab (source: ndc)
Application Number BLA761315 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, PLASTIC in 1 CARTON (0169-2084-15) / 1.5 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (1)

0169-2084-15 1 SYRINGE, PLASTIC in 1 CARTON (0169-2084-15) / 1.5 mL in 1 SYRINGE, PLASTIC

Ingredients (1)

concizumab (40 mg/mL)

Linked Drug Pages (1)

Alhemo ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "ff2589ac-650f-4740-984d-e950f785c1fc", "openfda": {"nui": ["N0000194160", "N0000194161"], "unii": ["68603V9EAF"], "rxcui": ["2708346", "2708353", "2708356", "2708359", "2708361", "2708362"], "spl_set_id": ["156f6404-1f6f-417f-bcf8-f07a27a82cc1"], "pharm_class_epc": ["Tissue Factor Pathway Inhibitor Antagonist [EPC]"], "pharm_class_moa": ["Tissue Factor Pathway Inhibitor Antagonists [MoA]"], "manufacturer_name": ["Novo Nordisk"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, PLASTIC in 1 CARTON (0169-2084-15)  / 1.5 mL in 1 SYRINGE, PLASTIC", "package_ndc": "0169-2084-15", "marketing_start_date": "20250219"}], "brand_name": "Alhemo", "product_id": "0169-2084_ff2589ac-650f-4740-984d-e950f785c1fc", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Tissue Factor Pathway Inhibitor Antagonist [EPC]", "Tissue Factor Pathway Inhibitor Antagonists [MoA]"], "product_ndc": "0169-2084", "generic_name": "concizumab", "labeler_name": "Novo Nordisk", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alhemo", "active_ingredients": [{"name": "CONCIZUMAB", "strength": "40 mg/mL"}], "application_number": "BLA761315", "marketing_category": "BLA", "marketing_start_date": "20250219", "listing_expiration_date": "20261231"}