Climara Pro
NDC Package 54868-5570-0

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Climara Pro is this medication contains 2 female hormones: an estrogen (estradiol) and a progestin (levonorgestrel). Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5570 and is authorized under FDA application NDA021258.

Identification & Billing

NDC Package Code
54868-5570-0
Package Description
4 PATCH in 1 CARTON
Product Code
54868-5570
11-Digit Billing Format
54868557000
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Climara Pro
Dosage Form
-
Usage Information
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.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA021258
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-13-2006
Listing Expiration
12-31-2017
Exclude Flag
I
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54868-5570-0 identifies a specific commercial package of 4 patch in 1 carton of Climara Pro, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 4 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Physicians Total Care, Inc. on April 13, 2006. The current certification is valid through December 31, 2017.

What are the primary indications for this medication?

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.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868557000. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 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 (5-4-1)
54868-5570-0
11-Digit CMS (5-4-2)
54868-5570-00

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