NDC 0378-3340 Xulane

Norelgestromin And Ethinyl Estradiol Patch Transdermal - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

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
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 Name: [5]
    Mylan Pharmaceuticals Inc.
    Labeler Code:
    0378
    FDA Application Number: [6]
    ANDA200910
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    04-16-2014
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 0378-3340-32

    Package Description: 1 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (0378-3340-17) / 7 d in 1 PATCH

    NDC Code 0378-3340-53

    Package Description: 3 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (0378-3340-16) / 7 d in 1 PATCH

    Price per Unit: $36.07778 per EA

    Product Details

    What is NDC 0378-3340?

    The NDC code 0378-3340 is assigned by the FDA to the product Xulane which is a human prescription drug product labeled by Mylan Pharmaceuticals Inc.. The generic name of Xulane is norelgestromin and ethinyl estradiol. The product's dosage form is patch and is administered via transdermal form. The product is distributed in 2 packages with assigned NDC codes 0378-3340-32 1 pouch in 1 carton / 1 patch in 1 pouch (0378-3340-17) / 7 d in 1 patch, 0378-3340-53 3 pouch in 1 carton / 1 patch in 1 pouch (0378-3340-16) / 7 d in 1 patch. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Xulane?

    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 Xulane Active Ingredients?

    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

    Which are Xulane UNII Codes?

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

    Which are Xulane Inactive Ingredients 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 Xulane?

    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 for Xulane?

    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 disclaimer below.

    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 disclaimer below.

    Product Footnotes

    [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".