Jalyn Capsule
NDC Package 80725-809-13

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

Package Information

Jalyn (dutasteride and tamsulosin hydrochloride) capsules is a medication used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). This formulation utilizes a capsule delivery system. Marketed by Waylis Therapeutics, this product is identified by NDC 80725-809 and is authorized under FDA application NDA022460.

Identification & Billing

NDC Package Code
80725-809-13
Package Description
30 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
80725-809
11-Digit Billing Format
80725080913
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 996097 - dutasteride 0.5 MG / tamsulosin HCl 0.4 MG Oral Capsule
  • RxCUI: 996097 - dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral Capsule
  • RxCUI: 996101 - Jalyn 0.5 MG / 0.4 MG Oral Capsule
  • RxCUI: 996101 - dutasteride 0.5 MG / tamsulosin hydrochloride 0.4 MG Oral Capsule [Jalyn]
  • RxCUI: 996101 - Jalyn (dutasteride 0.5 MG / tamsulosin HCl 0.4 MG) Oral Capsule

Clinical Specifications

Proprietary Name
Jalyn
Non-Proprietary Name
Dutasteride And Tamsulosin Hydrochloride
Substance Name
Dutasteride; Tamsulosin Hydrochloride
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This product is used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). Dutasteride works by reducing the size of the enlarged prostate. Tamsulosin is known as an alpha-blocker and works by relaxing muscles in the bladder and prostate. This product helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate frequently or urgently (including during the middle of the night). Dutasteride is not approved for prevention of prostate cancer. It may slightly increase the risk of developing a very serious form of prostate cancer. Talk to your doctor about the benefits and risks. This medication should not be used by women or children.

Regulatory & Marketing

Labeler Name
Waylis Therapeutics
Product Type
Human Prescription Drug
FDA Application #
NDA022460
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-01-2024
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (80725-809). Click a package code to view its specific billing and regulatory data.

80725-809-59
90 CAPSULE in 1 BOTTLE, PLASTIC

* 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 80725-809-13 identifies a specific commercial package of 30 capsule in 1 bottle, plastic of Jalyn, a human prescription drug labeled by Waylis Therapeutics. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This capsule is formulated for oral use and contains dutasteride; tamsulosin hydrochloride 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 Waylis Therapeutics on March 01, 2024. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This product is used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH). Dutasteride works by reducing the size of the enlarged prostate. Tamsulosin is known as an alpha-blocker and works by relaxing muscles in the bladder and prostate. This product helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate frequently or urgently (including during the middle of the night). Dutasteride is not approved for prevention of prostate cancer. It may slightly increase the risk of developing a very serious form of prostate cancer. Talk to your doctor about the benefits and risks. This medication should not be used by women or children.

How is this Waylis Therapeutics product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80725080913. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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)
80725-809-13
11-Digit CMS (5-4-2)
80725-0809-13

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