Aktipak
NDC Package 70363-007-04

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

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

Aktipak is a medication used to treat moderate acne. Marketed by Cutanea Life Sciences, Inc., this product is identified by NDC 70363-007 and is authorized under FDA application NDA050769.

Identification & Billing

NDC Package Code
70363-007-04
Package Description
4 POUCH in 1 PACKAGE / .8 g in 1 POUCH
Product Code
11-Digit Billing Format
70363000704

Clinical Specifications

Proprietary Name
Aktipak
Dosage Form
-
Usage Information
This product is used to treat moderate acne. It helps to reduce the number of pimples. This medication is a combination of 2 drugs. Erythromycin works by stopping the growth of acne-causing bacteria. It belongs to a class of drugs known as macrolide antibiotics. Benzoyl peroxide also kills acne-causing bacteria and causes the top layer of skin to dry and peel off so that new skin can form. This product also contains alcohol which helps to dry extra oils from the skin.

Regulatory & Marketing

Labeler Name
Cutanea Life Sciences, Inc.
FDA Application #
NDA050769
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-10-2017
End Marketing Date
09-30-2019
Listing Expiration
09-30-2019
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70363-007). Click a package code to view its specific billing and regulatory data.

2 POUCH in 1 PACKAGE / .8 g in 1 POUCH
60 POUCH in 1 CARTON / .8 g in 1 POUCH

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70363-007-04 identifies a specific commercial package of 4 pouch in 1 package / .8 g in 1 pouch of Aktipak, labeled by Cutanea Life Sciences, Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Cutanea Life Sciences, Inc. on April 10, 2017. The current certification is valid through September 30, 2019.

What are the primary indications for this medication?

This product is used to treat moderate acne. It helps to reduce the number of pimples. This medication is a combination of 2 drugs. Erythromycin works by stopping the growth of acne-causing bacteria. It belongs to a class of drugs known as macrolide antibiotics. Benzoyl peroxide also kills acne-causing bacteria and causes the top layer of skin to dry and peel off so that new skin can form. This product also contains alcohol which helps to dry extra oils from the skin.

How is this Cutanea Life Sciences, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70363000704. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
70363-007-04
11-Digit CMS (5-4-2)
70363-0007-04

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.