Methoxsalen Capsule, Liquid Filled
NDC Package 64380-752-16

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

Package Information

Methoxsalen capsules is a medication used along with controlled ultraviolet light (UVA) to help control severe psoriasis. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Strides Pharma Science Limited, this product is identified by NDC 64380-752 and is authorized under FDA application ANDA202687.

Identification & Billing

NDC Package Code
64380-752-16
Package Description
50 CAPSULE, LIQUID FILLED in 1 BOTTLE, GLASS
Product Code
64380-752
11-Digit Billing Format
64380075216
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
50 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Methoxsalen
Non-Proprietary Name
Methoxsalen
Substance Name
Methoxsalen
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METHOXSALEN 10 mg/1
Pharmacologic Class
Usage Information
This medication is used along with controlled ultraviolet light (UVA) to help control severe psoriasis. Methoxsalen works by making the skin more sensitive to UVA light. This combination helps to slow the overgrowth of skin cells. This medication is not recommended for use in children younger than 12 years.

Regulatory & Marketing

Labeler Name
Strides Pharma Science Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA202687
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-08-2016
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 64380-752-16 identifies a specific commercial package of 50 capsule, liquid filled in 1 bottle, glass of Methoxsalen, a human prescription drug labeled by Strides Pharma Science Limited. This product is billed for "EA" each discreet unit and contains an estimated amount of 50 billable units per package. This capsule, liquid filled is formulated for oral use and contains methoxsalen 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 Strides Pharma Science Limited on December 08, 2016. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used along with controlled ultraviolet light (UVA) to help control severe psoriasis. Methoxsalen works by making the skin more sensitive to UVA light. This combination helps to slow the overgrowth of skin cells. This medication is not recommended for use in children younger than 12 years.

How is this Strides Pharma Science Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64380075216. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 50 total billable units per package. 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)
64380-752-16
11-Digit CMS (5-4-2)
64380-0752-16

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