Climara Pro Patch
NDC 50419-491

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 50419-491?
  4. Climara Pro Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Pharmacologic Classes

Product Information

Climara Pro (estradiol and levonorgestrel) is a NDA-approved product labeled by Bayer Healthcare Pharmaceuticals Inc.. This medication contains 2 female hormones: an estrogen (estradiol) and a progestin (levonorgestrel). It is supplied as a patch for transdermal administration. This product entry covers the primary NDC 50419-491 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
50419-491
Proprietary Name:
Climara Pro
Non-Proprietary Name: [1]
Estradiol And Levonorgestrel
Substance Name: [2]
Estradiol; Levonorgestrel
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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): [4]
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.

Labeler & Regulatory Data

Labeler Name: [5]
Bayer Healthcare Pharmaceuticals Inc.
Labeler Code:
50419
Product Label ID:
184d3092-7fc6-4375-816b-1ab06bb99cfd
FDA Application Number: [6]
NDA021258
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
11-21-2003
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 50419-491?

The NDC code 50419-491 is assigned by the FDA to the product Climara Pro. It is commonly known by its generic name, estradiol and levonorgestrel. This pharmaceutical product is labeled by Bayer Healthcare Pharmaceuticals Inc. and is currently categorized as listed product. The medication is a patch administered via transdermal route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 50419-491-04, 50419-491-73. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ESTRADIOL .045 mg/d - The 17-beta-isomer of estradiol, an aromatized C18 steroid with hydroxyl group at 3-beta- and 17-beta-position. Estradiol-17-beta is the most potent form of mammalian estrogenic steroids.
  • LEVONORGESTREL .015 mg/d - A synthetic progestational hormone with actions similar to those of PROGESTERONE and about twice as potent as its racemic or (+-)-isomer (NORGESTREL). It is used for contraception, control of menstrual disorders, and treatment of endometriosis.

Which are the associated UNII Codes?

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

What is the NDC to RxNorm Crosswalk for this product?

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

Which are the Pharmacologic Classes of this product?

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".