Sevoflurane
NDC Package 58181-5200-1

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.

Sevoflurane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery.Sevoflurane should be administered only by persons trained in the administration of general anesthesia. Marketed by Nextsource Pharma, this product is identified by NDC 58181-5200 and is authorized under FDA application ANDA214382.

Identification & Billing

NDC Package Code
58181-5200-1
Package Description
1 BOTTLE, GLASS in 1 PACKAGE / 250 mL in 1 BOTTLE, GLASS
Product Code
58181-5200
11-Digit Billing Format
58181520001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sevoflurane
Dosage Form
-
Usage Information
Sevoflurane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery.Sevoflurane should be administered only by persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing predictable concentrations of sevoflurane should be used.

Regulatory & Marketing

Labeler Name
Nextsource Pharma
FDA Application #
ANDA214382
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-21-2024
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 58181-5200-1 identifies a specific commercial package of 1 bottle, glass in 1 package / 250 ml in 1 bottle, glass of Sevoflurane, labeled by Nextsource Pharma. 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 Nextsource Pharma on February 21, 2024. The current certification is valid through December 31, 2025.

How is this Nextsource Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58181520001. 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 (5-4-1)
58181-5200-1
11-Digit CMS (5-4-2)
58181-5200-01

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