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  5. NDC Package Code: 65219-672-01 Bomyntra

NDC Package 65219-672-01 Bomyntra

Denosumab Injection Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
65219-672-01
Package Description:
1 SYRINGE, PLASTIC in 1 CARTON / 1.7 mL in 1 SYRINGE, PLASTIC
Product Code:
65219-672
Proprietary Name:
Bomyntra
Non-Proprietary Name:
Denosumab
Substance Name:
Denosumab
Usage Information:
Denosumab is used to treat bone loss (osteoporosis) in people who have a high risk of getting fractures. Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases after menopause (in women), as you age, if someone in your family has osteoporosis, or if you take certain medications (such as prednisone) for long periods. This medication works by slowing bone loss to help maintain strong bones and reduce the risk of broken bones (fractures). Denosumab belongs to a class of drugs called monoclonal antibodies. It prevents certain cells in the body (osteoclasts) from breaking down bone.
11-Digit NDC Billing Format:
65219067201
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Fresenius Kabi Usa, Llc
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s):
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s):
DENOSUMAB 70 mg/mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
BLA761398
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
06-30-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 65219-672-01?

The NDC Packaged Code 65219-672-01 is assigned to a package of 1 syringe, plastic in 1 carton / 1.7 ml in 1 syringe, plastic of Bomyntra, a human prescription drug labeled by Fresenius Kabi Usa, Llc. The product's dosage form is injection and is administered via subcutaneous form.

Is NDC 65219-672 included in the NDC Directory?

Yes, Bomyntra with product code 65219-672 is active and included in the NDC Directory. The product was first marketed by Fresenius Kabi Usa, Llc on June 30, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 65219-672-01?

The 11-digit format is 65219067201. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-265219-672-015-4-265219-0672-01