Flumazenil Injection
NDC Package 0404-9860-05

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Flumazenil injection is adult Patients:Flumazenil injection 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 is indicated for the reversal of conscious sedation induced with benzodiazepines (see PRECAUTIONS: PEDIATRIC USE).CLOSECONTRAINDICATIONSFlumazenil injection is contraindicated:•in patients with a known hypersensitivity to flumazenil or benzodiazepines.•in patients who have been given a benzodiazepine for control of a potentially life-threatening condition (e.g., control of intracranial pressure or status epilepticus).•in patients who are showing signs of serious cyclic antidepressant overdose (see WARNINGS). This formulation utilizes a injection delivery system. Marketed by Henry Schein, Inc, this product is identified by NDC 0404-9860 and is authorized under FDA application ANDA076755.

Identification & Billing

NDC Package Code
0404-9860-05
Package Description
1 VIAL, MULTI-DOSE in 1 BAG / 5 mL in 1 VIAL, MULTI-DOSE
Product Code
0404-9860
11-Digit Billing Format
00404986005
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 - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
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 Patients:Flumazenil injection 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 is indicated for the reversal of conscious sedation induced with benzodiazepines (see PRECAUTIONS: PEDIATRIC USE).CLOSECONTRAINDICATIONSFlumazenil injection is contraindicated:•in patients with a known hypersensitivity to flumazenil or benzodiazepines.•in patients who have been given a benzodiazepine for control of a potentially life-threatening condition (e.g., control of intracranial pressure or status epilepticus).•in patients who are showing signs of serious cyclic antidepressant overdose (see WARNINGS).

Regulatory & Marketing

Labeler Name
Henry Schein, Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA076755
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-10-2022
End Marketing Date
07-31-2026
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 0404-9860-05 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 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 January 10, 2022.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00404986005. 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)
0404-9860-05
11-Digit CMS (5-4-2)
00404-9860-05

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