Remifentanil Hydrochloride
NDC Package 75834-232-10

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.

Remifentanil Hydrochloride is for injection is indicated for intravenous (IV) administration:As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures.For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting.As an analgesic component of monitored anesthesia care in adult patients. Marketed by Nivagen Pharmaceuticals, Inc., this product is identified by NDC 75834-232 and is authorized under FDA application ANDA215635.

Identification & Billing

NDC Package Code
75834-232-10
Package Description
10 VIAL, GLASS in 1 CARTON / 5 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (75834-232-01)
Product Code
75834-232
11-Digit Billing Format
75834023210
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Remifentanil Hydrochloride
Dosage Form
-
Usage Information
Remifentanil hydrochloride for injection is indicated for intravenous (IV) administration:As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures.For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting.As an analgesic component of monitored anesthesia care in adult patients.

Regulatory & Marketing

Labeler Name
Nivagen Pharmaceuticals, Inc.
FDA Application #
ANDA215635
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-04-2024
Listing Expiration
12-31-2025
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 75834-232-10 identifies a specific commercial package of 10 vial, glass in 1 carton / 5 injection, powder, lyophilized, for solution in 1 vial, glass (75834-232-01) of Remifentanil Hydrochloride, labeled by Nivagen Pharmaceuticals, Inc.. 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 Nivagen Pharmaceuticals, Inc. on September 04, 2024. The current certification is valid through December 31, 2025.

How is this Nivagen Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75834023210. 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)
75834-232-10
11-Digit CMS (5-4-2)
75834-0232-10

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