Entecavir Granule
NDC Package 52493-446-89

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Entecavir granules is see also Warning section. This formulation utilizes a granule delivery system. Marketed by Amneal Pharmaceuticals Co. (i) Pvt. Ltd., this product is identified by NDC 52493-446.

Identification & Billing

NDC Package Code
52493-446-89
Package Description
24 kg in 1 DRUM
Product Code
52493-446
11-Digit Billing Format
52493044689

Clinical Specifications

Proprietary Name
Entecavir
Non-Proprietary Name
Entecavir
Substance Name
Entecavir
Dosage Form
Granule - A small particle or grain.
Active Ingredient(s)
ENTECAVIR 1 kg/kg
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 Co. (i) Pvt. Ltd.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
09-20-2023
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 52493-446-89 identifies a specific commercial package of 24 kg in 1 drum of Entecavir (UNFINISHED drug), a bulk ingredient labeled by Amneal Pharmaceuticals Co. (i) Pvt. Ltd.. This granule is formulated for 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 Co. (i) Pvt. Ltd. on September 20, 2023. 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 Co. (i) Pvt. Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52493044689. 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)
52493-446-89
11-Digit CMS (5-4-2)
52493-0446-89

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