NDC Package 63557-2072-2 Eteplirsen

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

Package Information
Other Packages
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:

63557-2072-2

Package Description:

400 g in 1 BAG

Product Code:

63557-2072

Non-Proprietary Name:

Eteplirsen

Substance Name:

Eteplirsen

Usage Information:

Eteplirsen is used to treat a certain inherited muscle disorder (Duchenne muscular dystrophy-DMD). This disorder is caused by a lack of a certain muscle protein (dystrophin). This medication can increase the amount of dystrophin in your body.

11-Digit NDC Billing Format:

63557207202

Product Type:

Bulk Ingredient

Labeler Name:

Polypeptide Laboratories Inc

Dosage Form:

Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.

Active Ingredient(s):

ETEPLIRSEN 1 g/g

Sample Package:

N/A

Marketing Category:

BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.

Start Marketing Date:

09-01-2016

Listing Expiration Date:

12-31-2025

Exclude Flag:

Unfinished Product:

Yes

Code Structure:

63557 - Polypeptide Laboratories Inc
- 63557-2072 -
  - 63557-2072-2 - 400 g in 1 BAG

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
63557-2072-1	400 g in 1 BOTTLE, GLASS

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 63557-2072-2?

The NDC Packaged Code 63557-2072-2 is assigned to an UNFINISHED drug package of 400 g in 1 bag of Eteplirsen, a bulk ingredient labeled by Polypeptide Laboratories Inc. The product's dosage form is powder and is administered via form.

Is NDC 63557-2072 included in the NDC Directory?

Yes, Eteplirsen is an UNFINISHED PRODUCT with code 63557-2072 that is active and included in the NDC Directory. The product was first marketed by Polypeptide Laboratories Inc on September 01, 2016 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 63557-2072-2?

The 11-digit format is 63557207202. 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 5-4-1 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
5-4-1	63557-2072-2	5-4-2	63557-2072-02

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