xtrenbo

Generic: denosumab-qbde

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name xtrenbo
Generic Name denosumab-qbde
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

denosumab 120 mg/1.7mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9166
Product ID 0143-9166_70159c7c-a439-4a9c-82d4-8c6da6c345eb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761439
Listing Expiration 2027-12-31
Marketing Start 2026-01-08

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 01439166
Hyphenated Format 0143-9166

Supplemental Identifiers

RxCUI
2725590 2725597
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 xtrenbo (source: ndc)
Generic Name denosumab-qbde (source: ndc)
Application Number BLA761439 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 120 mg/1.7mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9166-01) / 1.7 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0143-9166-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9166-01) / 1.7 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

denosumab (120 mg/1.7mL)

Linked Drug Pages (1)

XTRENBO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "70159c7c-a439-4a9c-82d4-8c6da6c345eb", "openfda": {"nui": ["N0000187055", "N0000187054"], "unii": ["4EQZ6YO2HI"], "rxcui": ["2725590", "2725597"], "spl_set_id": ["a48a3a33-6b0e-4cf4-8786-8f662d6ee77b"], "pharm_class_epc": ["RANK Ligand Inhibitor [EPC]"], "pharm_class_moa": ["RANK Ligand Blocking Activity [MoA]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0143-9166-01)  / 1.7 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0143-9166-01", "marketing_start_date": "20260108"}], "brand_name": "XTRENBO", "product_id": "0143-9166_70159c7c-a439-4a9c-82d4-8c6da6c345eb", "dosage_form": "INJECTION", "pharm_class": ["RANK Ligand Blocking Activity [MoA]", "RANK Ligand Inhibitor [EPC]"], "product_ndc": "0143-9166", "generic_name": "Denosumab-qbde", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XTRENBO", "active_ingredients": [{"name": "DENOSUMAB", "strength": "120 mg/1.7mL"}], "application_number": "BLA761439", "marketing_category": "BLA", "marketing_start_date": "20260108", "listing_expiration_date": "20271231"}