Suprane Liquid
NDC Package 0404-9961-25

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

Package Information

Suprane (desflurane) liquids is 1.1 Induction of AnesthesiaSUPRANE is indicated as an inhalation agent for induction of anesthesia for inpatient and outpatient surgery in adults.SUPRANE is contraindicated as an inhalation agent for the induction of anesthesia in pediatric patients because of a high incidence of moderate to severe upper airway adverse events.1.2 Maintenance of AnesthesiaSUPRANE is indicated as an inhalation agent for maintenance of anesthesia for inpatient and outpatient surgery in adults and in pediatric patients.After induction of anesthesia with agents other than SUPRANE, and tracheal intubation, SUPRANE is indicated for maintenance of anesthesia in infants and children. This formulation utilizes a liquid delivery system. Marketed by Henry Schein, Inc., this product is identified by NDC 0404-9961 and is authorized under FDA application NDA020118.

Identification & Billing

NDC Package Code
0404-9961-25
Package Description
1 BOTTLE in 1 BAG / 240 mL in 1 BOTTLE
Product Code
0404-9961
11-Digit Billing Format
00404996125
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Suprane
Non-Proprietary Name
Desflurane
Substance Name
Desflurane
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)
DESFLURANE 240 mL/240mL
Pharmacologic Class
Usage Information
1.1 Induction of AnesthesiaSUPRANE is indicated as an inhalation agent for induction of anesthesia for inpatient and outpatient surgery in adults.SUPRANE is contraindicated as an inhalation agent for the induction of anesthesia in pediatric patients because of a high incidence of moderate to severe upper airway adverse events.1.2 Maintenance of AnesthesiaSUPRANE is indicated as an inhalation agent for maintenance of anesthesia for inpatient and outpatient surgery in adults and in pediatric patients.After induction of anesthesia with agents other than SUPRANE, and tracheal intubation, SUPRANE is indicated for maintenance of anesthesia in infants and children. SUPRANE is not approved for maintenance of anesthesia in non-intubated children due to an increased incidence of respiratory adverse reactions, including coughing, laryngospasm, and secretions [See WARNINGS AND PRECAUTIONS (5.3) and CLINICAL STUDIES (14.5)].

Regulatory & Marketing

Labeler Name
Henry Schein, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA020118
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-12-2022
Listing Expiration
12-31-2026
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 0404-9961-25 identifies a specific commercial package of 1 bottle in 1 bag / 240 ml in 1 bottle of Suprane, a human prescription drug labeled by Henry Schein, Inc.. This liquid is formulated for respiratory (inhalation) use and contains desflurane 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 Henry Schein, Inc. on January 12, 2022. The current certification is valid through December 31, 2026.

How is this Henry Schein, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00404996125. 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 (4-4-2)
0404-9961-25
11-Digit CMS (5-4-2)
00404-9961-25

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