NDC Package 0003-1612-12 Baraclude

Entecavir Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0003-1612-12
Package Description:
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Baraclude
Non-Proprietary Name:
Entecavir
Substance Name:
Entecavir
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).
11-Digit NDC Billing Format:
00003161212
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 485434 - entecavir 0.5 MG Oral Tablet
  • RxCUI: 485436 - entecavir 1 MG Oral Tablet
  • RxCUI: 485536 - entecavir 0.05 MG in 1 mL Oral Solution
  • RxCUI: 485536 - entecavir 0.05 MG/ML Oral Solution
  • RxCUI: 485536 - entecavir 0.05 MG per 1 ML Oral Solution
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    E.r. Squibb & Sons, L.l.c.
    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(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    NDA021797
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    03-29-2005
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 0003-1612-12?

    The NDC Packaged Code 0003-1612-12 is assigned to a package of 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle of Baraclude, a human prescription drug labeled by E.r. Squibb & Sons, L.l.c.. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 0003-1612 included in the NDC Directory?

    Yes, Baraclude with product code 0003-1612 is active and included in the NDC Directory. The product was first marketed by E.r. Squibb & Sons, L.l.c. on March 29, 2005 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0003-1612-12?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 0003-1612-12?

    The 11-digit format is 00003161212. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20003-1612-125-4-200003-1612-12