aukelso

Generic: denosumab-kyqq

Labeler: biocon biologics inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name aukelso
Generic Name denosumab-kyqq
Labeler biocon biologics inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

denosumab 120 mg/1.7mL

Manufacturer
Biocon Biologics Inc.

Identifiers & Regulatory

Product NDC 83257-030
Product ID 83257-030_09c9ae75-505b-dcae-8765-3628a32e7828
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761436
Listing Expiration 2026-12-31
Marketing Start 2026-01-05

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 83257030
Hyphenated Format 83257-030

Supplemental Identifiers

RxCUI
2725939 2725946
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 aukelso (source: ndc)
Generic Name denosumab-kyqq (source: ndc)
Application Number BLA761436 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 120 mg/1.7mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (83257-030-11) / 1.7 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

83257-030-11 1 VIAL, SINGLE-USE in 1 CARTON (83257-030-11) / 1.7 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

denosumab (120 mg/1.7mL)

Linked Drug Pages (1)

AUKELSO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "09c9ae75-505b-dcae-8765-3628a32e7828", "openfda": {"nui": ["N0000187055", "N0000187054"], "unii": ["4EQZ6YO2HI"], "rxcui": ["2725939", "2725946"], "spl_set_id": ["547cb095-f7f5-f933-75ce-5e6abf2ad5bc"], "pharm_class_epc": ["RANK Ligand Inhibitor [EPC]"], "pharm_class_moa": ["RANK Ligand Blocking Activity [MoA]"], "manufacturer_name": ["Biocon Biologics Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (83257-030-11)  / 1.7 mL in 1 VIAL, SINGLE-USE", "package_ndc": "83257-030-11", "marketing_start_date": "20260105"}], "brand_name": "AUKELSO", "product_id": "83257-030_09c9ae75-505b-dcae-8765-3628a32e7828", "dosage_form": "INJECTION", "pharm_class": ["RANK Ligand Blocking Activity [MoA]", "RANK Ligand Inhibitor [EPC]"], "product_ndc": "83257-030", "generic_name": "Denosumab-kyqq", "labeler_name": "Biocon Biologics Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AUKELSO", "active_ingredients": [{"name": "DENOSUMAB", "strength": "120 mg/1.7mL"}], "application_number": "BLA761436", "marketing_category": "BLA", "marketing_start_date": "20260105", "listing_expiration_date": "20261231"}