Flumazenil
NDC Package 70385-2002-1

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Flumazenil is  is contraindicated:in patients with a known hypersensitivity to flumazenil or benzodiazepines. Marketed by Sina Health Inc, this product is identified by NDC 70385-2002 and is authorized under FDA application ANDA078527.

Identification & Billing

NDC Package Code
70385-2002-1
Package Description
1 VIAL, MULTI-DOSE in 1 BAG / 5 mL in 1 VIAL, MULTI-DOSE
Product Code
70385-2002
11-Digit Billing Format
70385200201
RxNorm Crosswalk
RxCUI: 204508 - flumazenil 0.1 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Flumazenil
Dosage Form
-
Usage Information
Flumazenil 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
Sina Health Inc
FDA Application #
ANDA078527
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-01-2007
Listing Expiration
12-31-2020
Exclude Flag
I
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 70385-2002-1 identifies a specific commercial package of 1 vial, multi-dose in 1 bag / 5 ml in 1 vial, multi-dose of Flumazenil, labeled by Sina Health 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 Sina Health Inc on January 01, 2007. The current certification is valid through December 31, 2020.

How is this Sina Health Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70385200201. 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 (5-4-1)
70385-2002-1
11-Digit CMS (5-4-2)
70385-2002-01

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