Levulan Kerastick Kit
NDC Package 67308-101-06

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

Package Information

Levulan Kerastick (aminolevulinic acid hydrochloride) kits is the LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities. This formulation utilizes a kit delivery system. Marketed by Sun Pharmaceutical Industries, Inc, this product is identified by NDC 67308-101 and is authorized under FDA application NDA020965.

Identification & Billing

NDC Package Code
67308-101-06
Package Description
6 APPLICATOR in 1 CARTON / 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE
Product Code
11-Digit Billing Format
67308010106
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Levulan Kerastick
Non-Proprietary Name
Aminolevulinic Acid Hydrochloride
Dosage Form
Kit - A packaged collection of related material.
Usage Information
The LEVULAN KERASTICK for topical solution plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is indicated for the treatment of minimally to moderately thick actinic keratoses of the face, scalp, or upper extremities.

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA020965
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-04-2000
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

Source: ASP
Aminolevulinic acid hcl top
HCPCS Dosage 354 MG
Units / Pkg 6

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 (67308-101). Click a package code to view its specific billing and regulatory data.

1 KIT in 1 APPLICATOR * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE
2 APPLICATOR in 1 CARTON / 1 KIT in 1 APPLICATOR (67308-101-01) * 1.5 mL in 1 AMPULE * 1.5 mL in 1 AMPULE

* 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 67308-101-06 identifies a specific commercial package of 6 applicator in 1 carton / 1 kit in 1 applicator (67308-101-01) * 1.5 ml in 1 ampule * 1.5 ml in 1 ampule of Levulan Kerastick, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Sun Pharmaceutical Industries, Inc on September 04, 2000. The current certification is valid through December 31, 2026.

How is this Sun Pharmaceutical Industries, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67308010106. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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)
67308-101-06
11-Digit CMS (5-4-2)
67308-0101-06

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