oziltus

Generic: denosumab-mobz

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name oziltus
Generic Name denosumab-mobz
Labeler amneal pharmaceuticals llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

denosumab 70 mg/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-2701
Product ID 70121-2701_b34597a1-251b-4c4b-9457-c3de26d5c26e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761457
Listing Expiration 2026-12-31
Marketing Start 2025-12-23

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 701212701
Hyphenated Format 70121-2701

Supplemental Identifiers

RxCUI
2729323 2729330
UPC
0370121270119
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 oziltus (source: ndc)
Generic Name denosumab-mobz (source: ndc)
Application Number BLA761457 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 70 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (70121-2701-1) / 1.7 mL in 1 VIAL
source: ndc

Packages (1)

70121-2701-1 1 VIAL in 1 CARTON (70121-2701-1) / 1.7 mL in 1 VIAL

Ingredients (1)

denosumab (70 mg/mL)

Linked Drug Pages (1)

Oziltus ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "b34597a1-251b-4c4b-9457-c3de26d5c26e", "openfda": {"nui": ["N0000187055", "N0000187054"], "upc": ["0370121270119"], "unii": ["4EQZ6YO2HI"], "rxcui": ["2729323", "2729330"], "spl_set_id": ["f040a245-1be4-4962-a8b7-a13ee7fac707"], "pharm_class_epc": ["RANK Ligand Inhibitor [EPC]"], "pharm_class_moa": ["RANK Ligand Blocking Activity [MoA]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (70121-2701-1)  / 1.7 mL in 1 VIAL", "package_ndc": "70121-2701-1", "marketing_start_date": "20251223"}], "brand_name": "Oziltus", "product_id": "70121-2701_b34597a1-251b-4c4b-9457-c3de26d5c26e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["RANK Ligand Blocking Activity [MoA]", "RANK Ligand Inhibitor [EPC]"], "product_ndc": "70121-2701", "generic_name": "denosumab-mobz", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oziltus", "active_ingredients": [{"name": "DENOSUMAB", "strength": "70 mg/mL"}], "application_number": "BLA761457", "marketing_category": "BLA", "marketing_start_date": "20251223", "listing_expiration_date": "20261231"}