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  4. NDC Product Code: 11528-010 Covaryx

NDC 11528-010 Covaryx

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 11528-010?
  5. Covaryx 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.

Get all the details for National Drug Code (NDC) 11528-010 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:
11528-010
Proprietary Name:
Covaryx
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Centrix Pharmaceutical, Inc,
Labeler Code:
11528
Product Label ID:
e4ff7b6b-ce78-402c-9c0e-b8b0d9636eae
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date: [9]
04-01-2007
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328 - LIGHT PINK)
YELLOW (C48330 - LIGHT YELLOW)
Shape:
OVAL (C48345)
Size(s):
14 MM
Imprint(s):
PLAIN;C020
PLAIN;C010
Score:
1

Code Structure Chart

Product Details

What is NDC 11528-010?

The NDC code 11528-010 is assigned by the FDA to the product Covaryx which is product labeled by Centrix Pharmaceutical, Inc,. The product's dosage form is . The product is distributed in a single package with assigned NDC code 11528-010-01 100 tablet, coated 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 Covaryx?

COVARYXT® and COVARYX® H.S. are indicated in the treatment ofModerate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone. (There is no evidence that estrogens are effective for nervous symptoms or depression without associated vasomotor symptoms, and they should not be used to treat such conditions.)COVARYXT® and COVARYX® H.S. HAVE NOT BEEN SHOWN TO BE EFFECTIVE FOR ANY PURPOSE DURING PREGNANCY AND ITS USE MAY CAUSE SEVERE HARM TO THE FETUS (See BOXED WARNINGS).

Which are Covaryx UNII Codes?

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

Which are Covaryx 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 Covaryx?

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: 197670 - estrogens, esterified 1.25 MG / methylTESTOSTERone 2.5 MG Oral Tablet
  • RxCUI: 197670 - estrogens, esterified (USP) 1.25 MG / methyltestosterone 2.5 MG Oral Tablet
  • RxCUI: 197670 - EEMT DS Oral Tablet
  • RxCUI: 238006 - estrogens, esterified 0.625 MG / methylTESTOSTERone 1.25 MG Oral Tablet
  • RxCUI: 238006 - estrogens, esterified (USP) 0.625 MG / methyltestosterone 1.25 MG Oral Tablet

* 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.

[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".