Flumazenil Injection, Solution
NDC Package 0404-9793-05

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

Package Information

Flumazenil injection is adult PatientsFlumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.Pediatric Patients (aged 1 to 17)Flumazenil Injection, USP is indicated for the reversal of conscious sedation induced with benzodiazepines (see PRECAUTIONS: Pediatric Use). This formulation utilizes a injection, solution delivery system. Marketed by Henry Schein, Inc., this product is identified by NDC 0404-9793 and is authorized under FDA application ANDA078527.

Identification & Billing

NDC Package Code
0404-9793-05
Package Description
1 VIAL, MULTI-DOSE in 1 BAG / 5 mL in 1 VIAL, MULTI-DOSE
Product Code
0404-9793
11-Digit Billing Format
00404979305
RxNorm Crosswalk
RxCUI: 204508 - flumazenil 0.1 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Flumazenil
Non-Proprietary Name
Flumazenil
Substance Name
Flumazenil
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
FLUMAZENIL .1 mg/mL
Pharmacologic Class
Benzodiazepine Antagonist - [EPC] (Established Pharmacologic Class)
Usage Information
Adult PatientsFlumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.Pediatric Patients (aged 1 to 17)Flumazenil Injection, USP is indicated for the reversal of conscious sedation induced with benzodiazepines (see PRECAUTIONS: Pediatric Use).

Regulatory & Marketing

Labeler Name
Henry Schein, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA078527
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-14-2025
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 0404-9793-05 identifies a specific commercial package of 1 vial, multi-dose in 1 bag / 5 ml in 1 vial, multi-dose of Flumazenil, a human prescription drug labeled by Henry Schein, Inc.. This injection, solution is formulated for intravenous use and contains flumazenil 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 February 14, 2025. 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: 00404979305. 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)
0404-9793-05
11-Digit CMS (5-4-2)
00404-9793-05

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