conexxence

Generic: denosumab

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name conexxence
Generic Name denosumab
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

denosumab 60 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-668
Product ID 65219-668_f778a079-d075-4205-bc94-8ec67e27c95e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761398
Listing Expiration 2026-12-31
Marketing Start 2025-06-30

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 65219668
Hyphenated Format 65219-668

Supplemental Identifiers

RxCUI
2717531 2717538
UPC
0365219668015
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 conexxence (source: ndc)
Generic Name denosumab (source: ndc)
Application Number BLA761398 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 60 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, PLASTIC in 1 CARTON (65219-668-01) / 1 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (1)

65219-668-01 1 SYRINGE, PLASTIC in 1 CARTON (65219-668-01) / 1 mL in 1 SYRINGE, PLASTIC

Ingredients (1)

denosumab (60 mg/mL)

Linked Drug Pages (1)

CONEXXENCE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "f778a079-d075-4205-bc94-8ec67e27c95e", "openfda": {"nui": ["N0000187055", "N0000187054"], "upc": ["0365219668015"], "unii": ["4EQZ6YO2HI"], "rxcui": ["2717531", "2717538"], "spl_set_id": ["39a0a789-778f-4695-b3a9-61643e6396cd"], "pharm_class_epc": ["RANK Ligand Inhibitor [EPC]"], "pharm_class_moa": ["RANK Ligand Blocking Activity [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, PLASTIC in 1 CARTON (65219-668-01)  / 1 mL in 1 SYRINGE, PLASTIC", "package_ndc": "65219-668-01", "marketing_start_date": "20250630"}], "brand_name": "CONEXXENCE", "product_id": "65219-668_f778a079-d075-4205-bc94-8ec67e27c95e", "dosage_form": "INJECTION", "pharm_class": ["RANK Ligand Blocking Activity [MoA]", "RANK Ligand Inhibitor [EPC]"], "product_ndc": "65219-668", "generic_name": "Denosumab", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CONEXXENCE", "active_ingredients": [{"name": "DENOSUMAB", "strength": "60 mg/mL"}], "application_number": "BLA761398", "marketing_category": "BLA", "marketing_start_date": "20250630", "listing_expiration_date": "20261231"}