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  5. NDC Package Code: 0078-1315-10 Clarithromycin

NDC Package 0078-1315-10 Clarithromycin

Pellet - View Billable Units, 11-Digit Format, RxNorm

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.

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:
0078-1315-10
Package Description:
25000000 PELLET in 1 DRUM
Product Code:
0078-1315
Non-Proprietary Name:
Clarithromycin
Substance Name:
Clarithromycin
Usage Information:
Clarithromycin is used to treat a wide variety of bacterial infections. This medication can also be used in combination with anti-ulcer medications to treat certain types of stomach ulcers. It may also be used to prevent certain bacterial infections. Clarithromycin is known as a macrolide antibiotic. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.
11-Digit NDC Billing Format:
00078131510
Product Type:
Human Prescription Drug
Labeler Name:
Novartis Pharmaceuticals Corporation
Dosage Form:
Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.
Active Ingredient(s):
CLARITHROMYCIN 400 mg/1
Sample Package:
N/A
Marketing Category:
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date:
09-04-2007
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Unfinished Product:
Yes
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 0078-1315-10?

The NDC Packaged Code 0078-1315-10 is assigned to an UNFINISHED drug package of 25000000 pellet in 1 drum of Clarithromycin, a human prescription drug labeled by Novartis Pharmaceuticals Corporation. The product's dosage form is pellet and is administered via form.

Is NDC 0078-1315 included in the NDC Directory?

Yes, Clarithromycin is an UNFINISHED PRODUCT with code 0078-1315 that is active and included in the NDC Directory. The product was first marketed by Novartis Pharmaceuticals Corporation on September 04, 2007 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0078-1315-10?

The 11-digit format is 00078131510. 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
4-4-20078-1315-105-4-200078-1315-10