Rocuronium Injection, Solution
NDC Package 65219-697-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Rocuronium (rocuronium bromide) injection is rocuronium Bromide Injection is indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. This formulation utilizes a injection, solution delivery system. Marketed by Fresenius Kabi Usa, Llc, this product is identified by NDC 65219-697 and is authorized under FDA application NDA217472.

Identification & Billing

NDC Package Code
65219-697-10
Package Description
10 VIAL in 1 TRAY / 10 mL in 1 VIAL (65219-697-01)
Product Code
65219-697
11-Digit Billing Format
65219069710
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rocuronium
Non-Proprietary Name
Rocuronium Bromide
Substance Name
Rocuronium Bromide
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ROCURONIUM BROMIDE 10 mg/mL
Pharmacologic Class
Usage Information
Rocuronium Bromide Injection is indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Regulatory & Marketing

Labeler Name
Fresenius Kabi Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA217472
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-11-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 65219-697-10 identifies a specific commercial package of 10 vial in 1 tray / 10 ml in 1 vial (65219-697-01) of Rocuronium, a human prescription drug labeled by Fresenius Kabi Usa, Llc. This injection, solution is formulated for intravenous use and contains rocuronium bromide as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Fresenius Kabi Usa, Llc on October 11, 2023. The current certification is valid through December 31, 2026.

How is this Fresenius Kabi Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65219069710. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
65219-697-10
11-Digit CMS (5-4-2)
65219-0697-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.