jubbonti

Generic: denosumab

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name jubbonti
Generic Name denosumab
Labeler sandoz inc
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

denosumab 60 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-240
Product ID 61314-240_3f864a08-c693-4fdf-8158-c9e0d956fcad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761362
Listing Expiration 2026-12-31
Marketing Start 2025-06-02

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 61314240
Hyphenated Format 61314-240

Supplemental Identifiers

RxCUI
2715513 2715520
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 jubbonti (source: ndc)
Generic Name denosumab (source: ndc)
Application Number BLA761362 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 60 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (61314-240-63) / 1 mL in 1 SYRINGE
source: ndc

Packages (1)

61314-240-63 1 SYRINGE in 1 CARTON (61314-240-63) / 1 mL in 1 SYRINGE

Ingredients (1)

denosumab (60 mg/mL)

Linked Drug Pages (1)

JUBBONTI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "3f864a08-c693-4fdf-8158-c9e0d956fcad", "openfda": {"nui": ["N0000187055", "N0000187054"], "unii": ["4EQZ6YO2HI"], "rxcui": ["2715513", "2715520"], "spl_set_id": ["4bf239bb-c467-4add-b7cf-ea666e4fc693"], "pharm_class_epc": ["RANK Ligand Inhibitor [EPC]"], "pharm_class_moa": ["RANK Ligand Blocking Activity [MoA]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (61314-240-63)  / 1 mL in 1 SYRINGE", "package_ndc": "61314-240-63", "marketing_start_date": "20250602"}], "brand_name": "JUBBONTI", "product_id": "61314-240_3f864a08-c693-4fdf-8158-c9e0d956fcad", "dosage_form": "INJECTION", "pharm_class": ["RANK Ligand Blocking Activity [MoA]", "RANK Ligand Inhibitor [EPC]"], "product_ndc": "61314-240", "generic_name": "denosumab", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "JUBBONTI", "active_ingredients": [{"name": "DENOSUMAB", "strength": "60 mg/mL"}], "application_number": "BLA761362", "marketing_category": "BLA", "marketing_start_date": "20250602", "listing_expiration_date": "20261231"}