NDC Package 13551-101-05 Karbinal ER

View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:

13551-101-05

Package Description:

480 mL in 1 BOTTLE, PLASTIC

Product Code:

13551-101

Proprietary Name:

Karbinal ER

Usage Information:

Carbinoxamine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, watery eyes, itchy eyes/nose/throat/skin, cough, runny nose, and sneezing. This medication works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. By blocking another natural substance made by your body (acetylcholine), it helps dry up some body fluids to relieve symptoms such as watery eyes and runny nose. Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

11-Digit NDC Billing Format:

13551010105

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

480 ML

Labeler Name:

Avadel Pharmaceuticals (usa), Inc.

Sample Package:

FDA Application Number:

NDA022556

Marketing Category:

NDA - A product marketed under an approved New Drug Application.

Start Marketing Date:

01-03-2014

End Marketing Date:

02-16-2018

Listing Expiration Date:

02-16-2018

Exclude Flag:

Code Structure:

13551 - Avadel Pharmaceuticals (usa), Inc.
- 13551-101 - Karbinal
  - 13551-101-05 - 480 mL in 1 BOTTLE, PLASTIC

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 Code	Package Description
13551-101-01	2 BOTTLE, PLASTIC in 1 CARTON / 30 mL in 1 BOTTLE, PLASTIC

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 13551-101-05?

The NDC Packaged Code 13551-101-05 is assigned to a package of 480 ml in 1 bottle, plastic of Karbinal ER, labeled by Avadel Pharmaceuticals (usa), Inc.. The product's dosage form is and is administered via form.This product is billed per "ML" milliliter and contains an estimated amount of 480 billable units per package.

Is NDC 13551-101 included in the NDC Directory?

No, Karbinal ER with product code 13551-101 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Avadel Pharmaceuticals (usa), Inc. on January 03, 2014 and its listing in the NDC Directory is set to expire on February 16, 2018 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 13551-101-05?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 480.

What is the 11-digit format for NDC 13551-101-05?

The 11-digit format is 13551010105. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	13551-101-05	5-4-2	13551-0101-05

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