bilprevda

Generic: denosumab

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

Drug Facts

Product Profile

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

denosumab 120 mg/1.7mL

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-195
Product ID 78206-195_3e7e29ef-1e84-db7c-e063-6294a90a04d6
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 78206195
Hyphenated Format 78206-195

Supplemental Identifiers

RxCUI
2723338 2723345
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 bilprevda (source: ndc)
Generic Name denosumab (source: ndc)
Application Number BLA761444 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 120 mg/1.7mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (78206-195-01) / 1.7 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

78206-195-01 1 VIAL, SINGLE-DOSE in 1 CARTON (78206-195-01) / 1.7 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

denosumab (120 mg/1.7mL)

Linked Drug Pages (1)

Bilprevda ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "3e7e29ef-1e84-db7c-e063-6294a90a04d6", "openfda": {"nui": ["N0000187055", "N0000187054"], "unii": ["4EQZ6YO2HI"], "rxcui": ["2723338", "2723345"], "spl_set_id": ["b1f0590e-f5bb-44ac-99a0-4aa4596c7e54"], "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 VIAL, SINGLE-DOSE in 1 CARTON (78206-195-01)  / 1.7 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "78206-195-01", "marketing_start_date": "20250911"}], "brand_name": "Bilprevda", "product_id": "78206-195_3e7e29ef-1e84-db7c-e063-6294a90a04d6", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["RANK Ligand Blocking Activity [MoA]", "RANK Ligand Inhibitor [EPC]"], "product_ndc": "78206-195", "generic_name": "Denosumab", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bilprevda", "active_ingredients": [{"name": "DENOSUMAB", "strength": "120 mg/1.7mL"}], "application_number": "BLA761444", "marketing_category": "BLA", "marketing_start_date": "20250911", "listing_expiration_date": "20261231"}