bomyntra

Generic: denosumab

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name bomyntra
Generic Name denosumab
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

denosumab 70 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-672
Product ID 65219-672_fd3a3b73-bf8e-4538-9eee-b3d652251260
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761398
Listing Expiration 2026-12-31
Marketing Start 2025-06-30

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 65219672
Hyphenated Format 65219-672

Supplemental Identifiers

RxCUI
2717542 2717549 2717551 2717555
UPC
0365219672012 0365219670018
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 bomyntra (source: ndc)
Generic Name denosumab (source: ndc)
Application Number BLA761398 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 70 mg/mL
source: ndc
Packaging
  • 1 SYRINGE, PLASTIC in 1 CARTON (65219-672-01) / 1.7 mL in 1 SYRINGE, PLASTIC
source: ndc

Packages (1)

65219-672-01 1 SYRINGE, PLASTIC in 1 CARTON (65219-672-01) / 1.7 mL in 1 SYRINGE, PLASTIC

Ingredients (1)

denosumab (70 mg/mL)

Linked Drug Pages (1)

BOMYNTRA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "fd3a3b73-bf8e-4538-9eee-b3d652251260", "openfda": {"nui": ["N0000187055", "N0000187054"], "upc": ["0365219672012", "0365219670018"], "unii": ["4EQZ6YO2HI"], "rxcui": ["2717542", "2717549", "2717551", "2717555"], "spl_set_id": ["49d25732-e05d-47e4-98cb-67df04796d4b"], "pharm_class_epc": ["RANK Ligand Inhibitor [EPC]"], "pharm_class_moa": ["RANK Ligand Blocking Activity [MoA]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, PLASTIC in 1 CARTON (65219-672-01)  / 1.7 mL in 1 SYRINGE, PLASTIC", "package_ndc": "65219-672-01", "marketing_start_date": "20250630"}], "brand_name": "BOMYNTRA", "product_id": "65219-672_fd3a3b73-bf8e-4538-9eee-b3d652251260", "dosage_form": "INJECTION", "pharm_class": ["RANK Ligand Blocking Activity [MoA]", "RANK Ligand Inhibitor [EPC]"], "product_ndc": "65219-672", "generic_name": "Denosumab", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BOMYNTRA", "active_ingredients": [{"name": "DENOSUMAB", "strength": "70 mg/mL"}], "application_number": "BLA761398", "marketing_category": "BLA", "marketing_start_date": "20250630", "listing_expiration_date": "20261231"}