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  4. NDC Product Code: 54868-5570 Climara Pro

NDC 54868-5570 Climara Pro

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 54868-5570?
  4. Climara Pro Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. 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:
54868-5570
Proprietary Name:
Climara Pro
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
eabc0fb3-da2a-482f-83a7-99b1e823a150
Start Marketing Date: [9]
04-13-2006
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 54868-5570-0

Package Description: 4 PATCH in 1 CARTON

Product Details

What is NDC 54868-5570?

The NDC code 54868-5570 is assigned by the FDA to the product Climara Pro 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 54868-5570-0 4 patch in 1 carton . 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 Climara Pro?

This medication contains 2 female hormones: an estrogen (estradiol) and a progestin (levonorgestrel). It is used by women to help reduce a certain symptom of menopause (hot flashes). Symptoms of menopause are caused by the body making less estrogen. The progestin in this medication helps to reduce the risk of cancer of the uterus which can be caused by using estrogen. Women who have had their uterus removed do not need the progestin and therefore should not use this combination medication. If you are using this medication to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected. This medication may also be used by women after menopause to prevent bone loss (osteoporosis). However, there are other medications (such as raloxifene, bisphosphonates including alendronate) that are also effective in preventing bone loss and may be safer. These medications should be considered for use before estrogen/progestin treatment.

Which are Climara Pro UNII Codes?

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

Which are Climara Pro 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 Climara Pro?

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: 402250 - estradiol 0.045 MG / levonorgestrel 0.015 MG/Day Weekly Transdermal System
  • RxCUI: 402250 - 168 HR estradiol 0.00188 MG/HR / levonorgestrel 0.000625 MG/HR Transdermal System
  • RxCUI: 402250 - estradiol 0.00188 MG / levonorgestrel 0.000625 MG/HR Weekly Transdermal Patch
  • RxCUI: 402250 - estradiol 45 MCG / levonorgestrel 15 MCG/Day Weekly Transdermal Patch
  • RxCUI: 402252 - Climara Pro 0.045/0.015 MG/Day Weekly Transdermal System

* 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".