Rocuronium Bromide
NDC Package 71479-005-05

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Rocuronium Bromide is 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. Marketed by Sanovel Ilac San. Ve Tic.a.s., this product is identified by NDC 71479-005 and is authorized under FDA application ANDA210437.

Identification & Billing

NDC Package Code
71479-005-05
Package Description
10 VIAL, MULTI-DOSE in 1 BOX / 5 mL in 1 VIAL, MULTI-DOSE
Product Code
71479-005
11-Digit Billing Format
71479000505
RxNorm Crosswalk
  • RxCUI: 1234995 - rocuronium bromide 10 MG/ML Injectable Solution
  • RxCUI: 1234995 - rocuronium bromide 100 MG per 10 ML Concentrate for Injectable Solution
  • RxCUI: 1234995 - rocuronium bromide 50 MG per 5 ML Concentrate for Injectable Solution

Clinical Specifications

Proprietary Name
Rocuronium Bromide
Dosage Form
-
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
Sanovel Ilac San. Ve Tic.a.s.
FDA Application #
ANDA210437
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-31-2019
Listing Expiration
12-31-2020
Exclude Flag
I
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 71479-005-05 identifies a specific commercial package of 10 vial, multi-dose in 1 box / 5 ml in 1 vial, multi-dose of Rocuronium Bromide, labeled by Sanovel Ilac San. Ve Tic.a.s.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Sanovel Ilac San. Ve Tic.a.s. on December 31, 2019. The current certification is valid through December 31, 2020.

How is this Sanovel Ilac San. Ve Tic.a.s. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71479000505. 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)
71479-005-05
11-Digit CMS (5-4-2)
71479-0005-05

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