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  4. NDC Product Code: 80725-809 Jalyn

NDC 80725-809 Jalyn

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 80725-809?
  5. Jalyn Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing certification is expired.

Get all the details for National Drug Code (NDC) 80725-809 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
80725-809
Proprietary Name:
Jalyn
Product Type: [3]
EXPIRED PRODUCT and EXCLUDED from the NDC Directory
Labeler Name: [5]
Waylis Therapeutics
Labeler Code:
80725
Product Label ID:
aab9a2d4-5328-40f3-986f-e7753a928bc0
FDA Application Number: [6]
NDA022460
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
03-01-2024
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
E
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - OPAQUE DULL YELLOW)
Shape:
CAPSULE (C48336)
Size(s):
3 MM
Imprint(s):
GS;7CZ
Score:
1

Code Structure Chart

Product Details

What is NDC 80725-809?

The NDC code 80725-809 is assigned by the FDA to the product Jalyn which is product labeled by Waylis Therapeutics. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 80725-809-13 30 capsule in 1 bottle, plastic , 80725-809-59 90 capsule in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Jalyn?

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.

Which are Jalyn UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Jalyn Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Jalyn?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

* Please review the disclaimer below.

Patient Education

Dutasteride


Dutasteride is used alone or with another medication (tamsulosin [Flomax]) to treat benign prostatic hyperplasia (BPH; enlargement of the prostate gland). Dutasteride is used to treat symptoms of BPH and may reduce the chance of developing acute urinary retention (sudden inability to urinate). Dutasteride may also decrease the chance that prostate surgery will be needed. Dutasteride is in a class of medications called 5-alpha reductase inhibitors. It works by blocking the production of a natural substance that enlarges the prostate.
[Learn More]


Tamsulosin


Tamsulosin is used in men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia or BPH) which include difficulty urinating (hesitation, dribbling, weak stream, and incomplete bladder emptying), painful urination, and urinary frequency and urgency. Tamsulosin is in a class of medications called alpha blockers. It works by relaxing the muscles in the prostate and bladder so that urine can flow easily.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".