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  5. NDC Package Code: 50419-491-04 Climara Pro

NDC Package 50419-491-04 Climara Pro

Estradiol And Levonorgestrel Patch Transdermal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
50419-491-04
Package Description:
4 PATCH in 1 CARTON / 7 d in 1 PATCH
Product Code:
50419-491
Proprietary Name:
Climara Pro
Non-Proprietary Name:
Estradiol And Levonorgestrel
Substance Name:
Estradiol; Levonorgestrel
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.
11-Digit NDC Billing Format:
50419049104
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bayer Healthcare Pharmaceuticals Inc.
    Dosage Form:
    Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
    Administration Route(s):
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
    • Active Ingredient(s):
  • ESTRADIOL .045 mg/d
  • LEVONORGESTREL .015 mg/d
    • Pharmacologic Class(es):
  • Estradiol Congeners - [CS]
  • Estrogen Receptor Agonists - [MoA] (Mechanism of Action)
  • Estrogen - [EPC] (Established Pharmacologic Class)
  • Inhibit Ovum Fertilization - [PE] (Physiologic Effect)
  • Progesterone Congeners - [CS]
  • Progestin - [EPC] (Established Pharmacologic Class)
  • Progestin-containing Intrauterine System - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA021258
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-21-2003
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    50419-491-731 PATCH in 1 CARTON / 7 d in 1 PATCH

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 50419-491-04?

    The NDC Packaged Code 50419-491-04 is assigned to a package of 4 patch in 1 carton / 7 d in 1 patch of Climara Pro, a human prescription drug labeled by Bayer Healthcare Pharmaceuticals Inc.. The product's dosage form is patch and is administered via transdermal form.

    Is NDC 50419-491 included in the NDC Directory?

    Yes, Climara Pro with product code 50419-491 is active and included in the NDC Directory. The product was first marketed by Bayer Healthcare Pharmaceuticals Inc. on November 21, 2003 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 50419-491-04?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 50419-491-04?

    The 11-digit format is 50419049104. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-250419-491-045-4-250419-0491-04