Sevoflurane Liquid
NDC Package 42677-308-01

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

Package Information

Sevoflurane liquids is 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. This formulation utilizes a liquid delivery system. Marketed by Shandong New Time Pharmaceutical Co., Ltd., this product is identified by NDC 42677-308 and is authorized under FDA application ANDA214382.

Identification & Billing

NDC Package Code
42677-308-01
Package Description
1 BOTTLE, GLASS in 1 CARTON / 250 mL in 1 BOTTLE, GLASS
Product Code
42677-308
11-Digit Billing Format
42677030801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sevoflurane
Non-Proprietary Name
Sevoflurane
Substance Name
Sevoflurane
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Active Ingredient(s)
SEVOFLURANE 250 mL/250mL
Pharmacologic Class
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
Shandong New Time Pharmaceutical Co., Ltd.
Product Type
Human Prescription Drug
FDA Application #
ANDA214382
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-18-2023
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 42677-308-01 identifies a specific commercial package of 1 bottle, glass in 1 carton / 250 ml in 1 bottle, glass of Sevoflurane, a human prescription drug labeled by Shandong New Time Pharmaceutical Co., Ltd.. This liquid is formulated for respiratory (inhalation) use and contains sevoflurane 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 August 18, 2023. 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: 42677030801. 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)
42677-308-01
11-Digit CMS (5-4-2)
42677-0308-01

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