Entecavir
NDC Package 62227-101-03

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.

Entecavir is see also Warning section. Marketed by Brightgene Bio-medical Technology Co., Ltd., this product is identified by NDC 62227-101 and is authorized under FDA application ANDA212126.

Identification & Billing

NDC Package Code
62227-101-03
Package Description
3000 TABLET in 1 BOTTLE, PLASTIC
Product Code
62227-101
11-Digit Billing Format
62227010103

Clinical Specifications

Proprietary Name
Entecavir
Dosage Form
-
Usage Information
See also Warning section. Entecavir is used to treat long-term hepatitis B infection. Hepatitis B is an infection of the liver caused by the hepatitis B virus. Long-term infection can cause liver damage, rarely liver cancer, and liver failure. Entecavir helps to decrease the amount of hepatitis B virus in your body. It is unknown if this medication lowers your chance of getting liver cancer or liver damage. Entecavir is an antiviral that belongs to a class of drugs known as hepatitis B virus nucleoside reverse transcriptase inhibitors. Entecavir is not a cure for hepatitis B. It does not prevent the spread of the virus to others through sexual contact or blood/body fluid contamination (such as sharing used needles).

Regulatory & Marketing

Labeler Name
Brightgene Bio-medical Technology Co., Ltd.
FDA Application #
ANDA212126
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-08-2019
End Marketing Date
02-04-2023
Listing Expiration
02-04-2023
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 (62227-101). Click a package code to view its specific billing and regulatory data.

62227-101-01
30 TABLET in 1 BOTTLE, PLASTIC
62227-101-02
90 TABLET in 1 BOTTLE, PLASTIC

* 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 62227-101-03 identifies a specific commercial package of 3000 tablet in 1 bottle, plastic of Entecavir, labeled by Brightgene Bio-medical Technology Co., Ltd.. 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 Brightgene Bio-medical Technology Co., Ltd. on March 08, 2019. The current certification is valid through February 04, 2023.

What are the primary indications for this medication?

See also Warning section. Entecavir is used to treat long-term hepatitis B infection. Hepatitis B is an infection of the liver caused by the hepatitis B virus. Long-term infection can cause liver damage, rarely liver cancer, and liver failure. Entecavir helps to decrease the amount of hepatitis B virus in your body. It is unknown if this medication lowers your chance of getting liver cancer or liver damage. Entecavir is an antiviral that belongs to a class of drugs known as hepatitis B virus nucleoside reverse transcriptase inhibitors. Entecavir is not a cure for hepatitis B. It does not prevent the spread of the virus to others through sexual contact or blood/body fluid contamination (such as sharing used needles).

How is this Brightgene Bio-medical Technology Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62227010103. 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 (5-3-2)
62227-101-03
11-Digit CMS (5-4-2)
62227-0101-03

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