Flumazenil
NDC Package 0781-3003-95

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Flumazenil is a . Marketed by Sandoz Inc, this product is identified by NDC 0781-3003 and is authorized under FDA application ANDA077071.

Identification & Billing

NDC Package Code
0781-3003-95
Package Description
10 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE (0781-3003-70)
Product Code
0781-3003
11-Digit Billing Format
00781300395
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Flumazenil
Dosage Form
-

Regulatory & Marketing

Labeler Name
Sandoz Inc
FDA Application #
ANDA077071
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-03-2005
End Marketing Date
08-31-2015
Listing Expiration
08-31-2015
Exclude Flag
D
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0781-3003). Click a package code to view its specific billing and regulatory data.

0781-3003-92
10 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE (0781-3003-75)

* 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 0781-3003-95 identifies a specific commercial package of 10 vial, multi-dose in 1 carton / 10 ml in 1 vial, multi-dose (0781-3003-70) of Flumazenil, labeled by Sandoz Inc. 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 Sandoz Inc on May 03, 2005. The current certification is valid through August 31, 2015.

How is this Sandoz Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00781300395. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
0781-3003-95
11-Digit CMS (5-4-2)
00781-3003-95

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