Baraclude Solution
NDC Package 0003-1614-12

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

Package Information

Baraclude (entecavir) solution is see also Warning section. This formulation utilizes a solution delivery system. Marketed by E.r. Squibb & Sons, L.l.c., this product is identified by NDC 0003-1614 and is authorized under FDA application NDA021798.

Identification & Billing

NDC Package Code
0003-1614-12
Package Description
1 BOTTLE in 1 CARTON / 210 mL in 1 BOTTLE
Product Code
0003-1614
11-Digit Billing Format
00003161412
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Baraclude
Non-Proprietary Name
Entecavir
Substance Name
Entecavir
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ENTECAVIR .05 mg/mL
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
E.r. Squibb & Sons, L.l.c.
Product Type
Human Prescription Drug
FDA Application #
NDA021798
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-29-2005
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 0003-1614-12 identifies a specific commercial package of 1 bottle in 1 carton / 210 ml in 1 bottle of Baraclude, a human prescription drug labeled by E.r. Squibb & Sons, L.l.c.. This solution 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 E.r. Squibb & Sons, L.l.c. on March 29, 2005. 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 E.r. Squibb & Sons, L.l.c. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00003161412. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0003-1614-12
11-Digit CMS (5-4-2)
00003-1614-12

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