Rocuronium Bromide Injection, Solution
NDC Package 42677-310-10

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

Package Information

Rocuronium Bromide injection is indicated for inpatients and outpatients 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 Shandong New Time Pharmaceutical Co., Ltd., this product is identified by NDC 42677-310 and is authorized under FDA application ANDA215684.

Identification & Billing

NDC Package Code
42677-310-10
Package Description
10 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE (42677-310-01)
Product Code
42677-310
11-Digit Billing Format
42677031010

Clinical Specifications

Proprietary Name
Rocuronium Bromide
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 100 mg/10mL
Pharmacologic Class
Usage Information
Rocuronium bromide injection is indicated for inpatients and outpatients 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
Shandong New Time Pharmaceutical Co., Ltd.
Product Type
Human Prescription Drug
FDA Application #
ANDA215684
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-12-2024
Listing Expiration
12-31-2027
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 42677-310-10 identifies a specific commercial package of 10 vial, multi-dose in 1 carton / 10 ml in 1 vial, multi-dose (42677-310-01) of Rocuronium Bromide, a human prescription drug labeled by Shandong New Time Pharmaceutical Co., Ltd.. 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 Shandong New Time Pharmaceutical Co., Ltd. on July 12, 2024. The current certification is valid through December 31, 2027.

How is this Shandong New Time Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42677031010. 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)
42677-310-10
11-Digit CMS (5-4-2)
42677-0310-10

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