Xulane Patch
NDC 0378-3340

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0378-3340?
  4. Xulane Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

Xulane (norelgestromin and ethinyl estradiol) is a ANDA-approved product labeled by Mylan Pharmaceuticals Inc.. This patch contains combination hormone medication and is used to prevent pregnancy. It is supplied as a patch for transdermal administration. This product entry covers the primary NDC 0378-3340 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0378-3340
Proprietary Name:
Xulane
Non-Proprietary Name: [1]
Norelgestromin And Ethinyl Estradiol
Substance Name: [2]
Ethinyl Estradiol; Norelgestromin
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]
Mylan Pharmaceuticals Inc.
Labeler Code:
0378
Product Label ID:
f7848550-086a-43d8-8ae5-047f4b9e4382
FDA Application Number: [6]
ANDA200910
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
04-16-2014
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 0378-3340?

The NDC code 0378-3340 is assigned by the FDA to the product Xulane. It is commonly known by its generic name, norelgestromin and ethinyl estradiol. This pharmaceutical product is labeled by Mylan 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: 0378-3340-32, 0378-3340-53. 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 patch contains combination hormone medication and is used to prevent pregnancy. It contains 2 hormones: a progestin (norelgestromin) and an estrogen (ethinyl estradiol). It works mainly by preventing the release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. If a fertilized egg does not attach to the uterus, it passes out of the body. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

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.
  • ETHINYL ESTRADIOL 35 ug/d - A semisynthetic alkylated ESTRADIOL with a 17-alpha-ethinyl substitution. It has high estrogenic potency when administered orally, and is often used as the estrogenic component in ORAL CONTRACEPTIVES.
  • NORELGESTROMIN 150 ug/d - transdermal hormonal contraceptive

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 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: 1534809 - norelgestromin 150 MCG / ethinyl estradiol 35 MCG/Day Weekly Transdermal System
  • RxCUI: 1534809 - 168 HR ethinyl estradiol 0.00146 MG/HR / norelgestromin 0.00625 MG/HR Transdermal System
  • RxCUI: 1534809 - ethinyl estradiol 35 MCG / norelgestromin 150 MCG per 24HR 7 Day Transdermal Patch
  • RxCUI: 1536586 - Xulane 150/35 MCG/Day Weekly Transdermal System
  • RxCUI: 1536586 - 168 HR ethinyl estradiol 0.00146 MG/HR / norelgestromin 0.00625 MG/HR Transdermal System [Xulane]

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the full disclaimer at the bottom of this page.

Patient Education

Estrogen and Progestin (Transdermal Patch Contraceptives)


Estrogen and progestin transdermal (patch) contraceptives are used to prevent pregnancy. Estrogen (ethinyl estradiol) and progestin (levonorgestrel or norelgestromin) are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries) and by changing the cervical mucus and the lining of the uterus. The contraceptive patch is a very effective method of birth control, but it does not prevent the spread of human immunodeficiency virus (HIV; the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

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".