NDC Package 43547-437-15 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:
43547-437-15
Package Description:
500 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Entecavir
Non-Proprietary Name:
Entecavir
Substance Name:
Entecavir Anhydrous
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:
43547043715
NDC to RxNorm Crosswalk:
  • RxCUI: 485434 - entecavir 0.5 MG Oral Tablet
  • RxCUI: 485436 - entecavir 1 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Solco Healthcare Llc
    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:
    ANDA208782
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-01-2018
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    43547-437-0330 TABLET, FILM COATED in 1 BOTTLE
    43547-437-0990 TABLET, FILM COATED in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43547-437-15?

    The NDC Packaged Code 43547-437-15 is assigned to a package of 500 tablet, film coated in 1 bottle of Entecavir, a human prescription drug labeled by Solco Healthcare Llc. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 43547-437 included in the NDC Directory?

    Yes, Entecavir with product code 43547-437 is active and included in the NDC Directory. The product was first marketed by Solco Healthcare Llc on April 01, 2018 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 11-digit format for NDC 43547-437-15?

    The 11-digit format is 43547043715. 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 5-3-2 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
    5-3-243547-437-155-4-243547-0437-15