Entecavir Tablet, Film Coated
NDC Package 65162-446-03

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

Package Information

Entecavir tablets is see also Warning section. This formulation utilizes a tablet, film coated delivery system. Marketed by Amneal Pharmaceuticals Llc, this product is identified by NDC 65162-446 and is authorized under FDA application ANDA206652.

Identification & Billing

NDC Package Code
65162-446-03
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
65162-446
11-Digit Billing Format
65162044603
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Entecavir
Non-Proprietary Name
Entecavir
Substance Name
Entecavir
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ENTECAVIR .5 mg/1
Pharmacologic Class
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
Amneal Pharmaceuticals Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA206652
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-28-2014
Listing Expiration
12-31-2026
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 65162-446-03 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Entecavir, a human prescription drug labeled by Amneal Pharmaceuticals Llc. This tablet, film coated is formulated for oral use and contains entecavir 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 Amneal Pharmaceuticals Llc on November 28, 2014. The current certification is valid through December 31, 2026.

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 Amneal Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65162044603. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
65162-446-03
11-Digit CMS (5-4-2)
65162-0446-03

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