Zyclara
NDC Package 29336-710-28

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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

Zyclara is imiquimod is used to treat actinic keratoses (AK) which are precancerous growths on the skin. Marketed by Graceway Pharmaceuticals, Llc, this product is identified by NDC 29336-710 and is authorized under FDA application NDA022483.

Identification & Billing

NDC Package Code
29336-710-28
Package Description
28 PACKET in 1 CARTON / 250 mg in 1 PACKET
Product Code
29336-710
11-Digit Billing Format
29336071028

Clinical Specifications

Proprietary Name
Zyclara
Dosage Form
-
Usage Information
Imiquimod is used to treat actinic keratoses (AK) which are precancerous growths on the skin. AK are caused by too much sun exposure. Treating this condition can decrease the risk of complications from them. It is also used to treat warts on the outside of the genitals/anus. Imiquimod belongs to a group of drugs called immune response modifiers. It is believed to work by helping to activate your immune system to fight these abnormal skin growths. This product is not recommended for use on children under 12 years of age unless specifically directed by your doctor.

Regulatory & Marketing

Labeler Name
Graceway Pharmaceuticals, Llc
FDA Application #
NDA022483
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-15-2011
End Marketing Date
01-31-2015
Listing Expiration
01-31-2015
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 29336-710-28 identifies a specific commercial package of 28 packet in 1 carton / 250 mg in 1 packet of Zyclara, labeled by Graceway Pharmaceuticals, Llc. 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 Graceway Pharmaceuticals, Llc on August 15, 2011. The current certification is valid through January 31, 2015.

What are the primary indications for this medication?

Imiquimod is used to treat actinic keratoses (AK) which are precancerous growths on the skin. AK are caused by too much sun exposure. Treating this condition can decrease the risk of complications from them. It is also used to treat warts on the outside of the genitals/anus. Imiquimod belongs to a group of drugs called immune response modifiers. It is believed to work by helping to activate your immune system to fight these abnormal skin growths. This product is not recommended for use on children under 12 years of age unless specifically directed by your doctor.

How is this Graceway Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 29336071028. 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)
29336-710-28
11-Digit CMS (5-4-2)
29336-0710-28

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