enoby

Generic: denosumab-qbde

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

Drug Facts

Product Profile

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

denosumab 60 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9165
Product ID 0143-9165_ddf6eb2a-4e1f-4cb4-992a-c93cbb5c0cfb
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 01439165
Hyphenated Format 0143-9165

Supplemental Identifiers

RxCUI
2725566 2725573
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 enoby (source: ndc)
Generic Name denosumab-qbde (source: ndc)
Application Number BLA761439 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 60 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (0143-9165-01) / 1 mL in 1 SYRINGE
source: ndc

Packages (1)

0143-9165-01 1 SYRINGE in 1 CARTON (0143-9165-01) / 1 mL in 1 SYRINGE

Ingredients (1)

denosumab (60 mg/mL)

Linked Drug Pages (1)

ENOBY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "ddf6eb2a-4e1f-4cb4-992a-c93cbb5c0cfb", "openfda": {"nui": ["N0000187055", "N0000187054"], "unii": ["4EQZ6YO2HI"], "rxcui": ["2725566", "2725573"], "spl_set_id": ["815d3ba4-27a1-4a06-925a-a87f35442bdb"], "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 SYRINGE in 1 CARTON (0143-9165-01)  / 1 mL in 1 SYRINGE", "package_ndc": "0143-9165-01", "marketing_start_date": "20260108"}], "brand_name": "ENOBY", "product_id": "0143-9165_ddf6eb2a-4e1f-4cb4-992a-c93cbb5c0cfb", "dosage_form": "INJECTION", "pharm_class": ["RANK Ligand Blocking Activity [MoA]", "RANK Ligand Inhibitor [EPC]"], "product_ndc": "0143-9165", "generic_name": "Denosumab-qbde", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ENOBY", "active_ingredients": [{"name": "DENOSUMAB", "strength": "60 mg/mL"}], "application_number": "BLA761439", "marketing_category": "BLA", "marketing_start_date": "20260108", "listing_expiration_date": "20271231"}