Entecavir
NDC Package 49884-104-11

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 discontinued by the firm.

Entecavir is see also Warning section. Marketed by Par Pharmaceutical Inc., this product is identified by NDC 49884-104 and is authorized under FDA application NDA021797.

Identification & Billing

NDC Package Code
49884-104-11
Package Description
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
Product Code
49884-104
11-Digit Billing Format
49884010411
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA

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
Par Pharmaceutical Inc.
FDA Application #
NDA021797
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
08-18-2014
End Marketing Date
08-31-2017
Listing Expiration
08-31-2017
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49884-104-11 identifies a specific commercial package of 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle of Entecavir, labeled by Par Pharmaceutical 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 Par Pharmaceutical Inc. on August 18, 2014. The current certification is valid through August 31, 2017.

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 Par Pharmaceutical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49884010411. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
49884-104-11
11-Digit CMS (5-4-2)
49884-0104-11

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