NDC 50419-491 Climara Pro
Estradiol And Levonorgestrel Patch Transdermal - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Code Structure Chart
Product Details
What is NDC 50419-491?
What are the uses for Climara Pro?
What are Climara Pro Active Ingredients?
- 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 Climara Pro UNII Codes?
The UNII codes for the active ingredients in this product are:
- ESTRADIOL (UNII: 4TI98Z838E)
- ESTRADIOL (UNII: 4TI98Z838E) (Active Moiety)
- LEVONORGESTREL (UNII: 5W7SIA7YZW)
- LEVONORGESTREL (UNII: 5W7SIA7YZW) (Active Moiety)
What is the NDC to RxNorm Crosswalk for Climara Pro?
- 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 for Climara Pro?
- 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)
* Please review the disclaimer below.
[1] 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.
[2] 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.
[3] 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.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] 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.
[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 ("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".