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  4. NDC Product Code: 54868-6328 Jalyn

NDC 54868-6328 Jalyn

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54868-6328?
  5. Jalyn Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
54868-6328
Proprietary Name:
Jalyn
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
f96c6acd-4d02-4ece-bd54-2d5a35aab7f5
Start Marketing Date: [9]
05-02-2012
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
BROWN (C48332 - BROWN BODY AND A ORANGE CAP)
Shape:
CAPSULE (C48336)
Size(s):
23 MM
Imprint(s):
GZ;7CZ
Score:
1

Code Structure Chart

Product Details

What is NDC 54868-6328?

The NDC code 54868-6328 is assigned by the FDA to the product Jalyn which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 54868-6328-0 30 capsule in 1 bottle . 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.

Product Footnotes

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

[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".