ospomyv

Generic: denosumab

Labeler: cordavis limited
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name ospomyv
Generic Name denosumab
Labeler cordavis limited
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

denosumab 60 mg/mL

Manufacturer
Cordavis Limited

Identifiers & Regulatory

Product NDC 83457-012
Product ID 83457-012_701ab9b4-0ad7-4b34-b66f-f75b41d0e1e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761392
Listing Expiration 2026-12-31
Marketing Start 2025-10-10

Pharmacologic Class

Established (EPC)
rank ligand inhibitor [epc]
Mechanism of Action
rank ligand blocking activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83457012
Hyphenated Format 83457-012

Supplemental Identifiers

RxCUI
2725502 2725509
UNII
4EQZ6YO2HI
NUI
N0000187055 N0000187054

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 ospomyv (source: ndc)
Generic Name denosumab (source: ndc)
Application Number BLA761392 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 60 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (83457-012-10) / 1 mL in 1 SYRINGE
source: ndc

Packages (1)

83457-012-10 1 SYRINGE in 1 CARTON (83457-012-10) / 1 mL in 1 SYRINGE

Ingredients (1)

denosumab (60 mg/mL)

Linked Drug Pages (1)

OSPOMYV ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "701ab9b4-0ad7-4b34-b66f-f75b41d0e1e9", "openfda": {"nui": ["N0000187055", "N0000187054"], "unii": ["4EQZ6YO2HI"], "rxcui": ["2725502", "2725509"], "spl_set_id": ["e1d80a82-de52-4a34-9df3-609e50667ffb"], "pharm_class_epc": ["RANK Ligand Inhibitor [EPC]"], "pharm_class_moa": ["RANK Ligand Blocking Activity [MoA]"], "manufacturer_name": ["Cordavis Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (83457-012-10)  / 1 mL in 1 SYRINGE", "package_ndc": "83457-012-10", "marketing_start_date": "20251010"}], "brand_name": "OSPOMYV", "product_id": "83457-012_701ab9b4-0ad7-4b34-b66f-f75b41d0e1e9", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["RANK Ligand Blocking Activity [MoA]", "RANK Ligand Inhibitor [EPC]"], "product_ndc": "83457-012", "generic_name": "denosumab", "labeler_name": "Cordavis Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OSPOMYV", "active_ingredients": [{"name": "DENOSUMAB", "strength": "60 mg/mL"}], "application_number": "BLA761392", "marketing_category": "BLA", "marketing_start_date": "20251010", "listing_expiration_date": "20261231"}