prolia

Generic: denosumab

Labeler: amgen, inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name prolia
Generic Name denosumab
Labeler amgen, inc
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

denosumab 60 mg/mL

Manufacturer
Amgen, Inc

Identifiers & Regulatory

Product NDC 55513-710
Product ID 55513-710_f5a330b4-e272-4aa1-9fce-afdfce5543aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125320
Listing Expiration 2026-12-31
Marketing Start 2010-06-05

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 55513710
Hyphenated Format 55513-710

Supplemental Identifiers

RxCUI
993452 993456
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 prolia (source: ndc)
Generic Name denosumab (source: ndc)
Application Number BLA125320 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 60 mg/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (55513-710-01) / 1 mL in 1 SYRINGE
  • 1 SYRINGE in 1 CARTON (55513-710-21) / 1 mL in 1 SYRINGE
source: ndc

Packages (2)

55513-710-01 1 SYRINGE in 1 CARTON (55513-710-01) / 1 mL in 1 SYRINGE 55513-710-21 1 SYRINGE in 1 CARTON (55513-710-21) / 1 mL in 1 SYRINGE

Ingredients (1)

denosumab (60 mg/mL)

Linked Drug Pages (1)

Prolia ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "f5a330b4-e272-4aa1-9fce-afdfce5543aa", "openfda": {"nui": ["N0000187055", "N0000187054"], "unii": ["4EQZ6YO2HI"], "rxcui": ["993452", "993456"], "spl_set_id": ["49e5afe9-a0c7-40c4-af9f-f287a80c5c88"], "pharm_class_epc": ["RANK Ligand Inhibitor [EPC]"], "pharm_class_moa": ["RANK Ligand Blocking Activity [MoA]"], "manufacturer_name": ["Amgen, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (55513-710-01)  / 1 mL in 1 SYRINGE", "package_ndc": "55513-710-01", "marketing_start_date": "20100605"}, {"sample": false, "description": "1 SYRINGE in 1 CARTON (55513-710-21)  / 1 mL in 1 SYRINGE", "package_ndc": "55513-710-21", "marketing_start_date": "20240305"}], "brand_name": "Prolia", "product_id": "55513-710_f5a330b4-e272-4aa1-9fce-afdfce5543aa", "dosage_form": "INJECTION", "pharm_class": ["RANK Ligand Blocking Activity [MoA]", "RANK Ligand Inhibitor [EPC]"], "product_ndc": "55513-710", "generic_name": "denosumab", "labeler_name": "Amgen, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Prolia", "active_ingredients": [{"name": "DENOSUMAB", "strength": "60 mg/mL"}], "application_number": "BLA125320", "marketing_category": "BLA", "marketing_start_date": "20100605", "listing_expiration_date": "20261231"}