bildyos

Generic: denosumab

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name bildyos
Generic Name denosumab
Labeler organon llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

denosumab 60 mg/mL

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-193
Product ID 78206-193_3e7e35c0-50a6-0266-e063-6394a90a3736
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761444
Listing Expiration 2026-12-31
Marketing Start 2025-09-11

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 78206193
Hyphenated Format 78206-193

Supplemental Identifiers

RxCUI
2723350 2723357
UPC
0378206193018
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 bildyos (source: ndc)
Generic Name denosumab (source: ndc)
Application Number BLA761444 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 60 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (78206-193-01) / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

78206-193-01 1 SYRINGE, GLASS in 1 CARTON (78206-193-01) / 1 mL in 1 SYRINGE, GLASS

Ingredients (1)

denosumab (60 mg/mL)

Linked Drug Pages (1)

BILDYOS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "3e7e35c0-50a6-0266-e063-6394a90a3736", "openfda": {"nui": ["N0000187055", "N0000187054"], "upc": ["0378206193018"], "unii": ["4EQZ6YO2HI"], "rxcui": ["2723350", "2723357"], "spl_set_id": ["b9e32bf7-d70a-4083-8577-c15751c7f769"], "pharm_class_epc": ["RANK Ligand Inhibitor [EPC]"], "pharm_class_moa": ["RANK Ligand Blocking Activity [MoA]"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (78206-193-01)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "78206-193-01", "marketing_start_date": "20250911"}], "brand_name": "BILDYOS", "product_id": "78206-193_3e7e35c0-50a6-0266-e063-6394a90a3736", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["RANK Ligand Blocking Activity [MoA]", "RANK Ligand Inhibitor [EPC]"], "product_ndc": "78206-193", "generic_name": "Denosumab", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BILDYOS", "active_ingredients": [{"name": "DENOSUMAB", "strength": "60 mg/mL"}], "application_number": "BLA761444", "marketing_category": "BLA", "marketing_start_date": "20250911", "listing_expiration_date": "20261231"}