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  5. NDC Package Code: 0378-3340-32 Xulane

NDC Package 0378-3340-32 Xulane

Norelgestromin And Ethinyl Estradiol 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:
0378-3340-32
Package Description:
1 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (0378-3340-17) / 7 d in 1 PATCH
Product Code:
0378-3340
Proprietary Name:
Xulane
Non-Proprietary Name:
Norelgestromin And Ethinyl Estradiol
Substance Name:
Ethinyl Estradiol; Norelgestromin
Usage Information:
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).
11-Digit NDC Billing Format:
00378334032
NDC to RxNorm Crosswalk:
  • 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]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mylan 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):
  • ETHINYL ESTRADIOL 35 ug/d
  • NORELGESTROMIN 150 ug/d
    • Pharmacologic Class(es):
  • Estrogen Receptor Agonists - [MoA] (Mechanism of Action)
  • Estrogen - [EPC] (Established Pharmacologic Class)
  • Progesterone Congeners - [CS]
  • Progestin - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    Yes
    FDA Application Number:
    ANDA200910
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-16-2014
    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
    0378-3340-533 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (0378-3340-16) / 7 d in 1 PATCH

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0378-3340-32?

    The NDC Packaged Code 0378-3340-32 is assigned to a package of 1 pouch in 1 carton / 1 patch in 1 pouch (0378-3340-17) / 7 d in 1 patch of Xulane, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. The product's dosage form is patch and is administered via transdermal form.

    Is NDC 0378-3340 included in the NDC Directory?

    Yes, Xulane with product code 0378-3340 is active and included in the NDC Directory. The product was first marketed by Mylan Pharmaceuticals Inc. on April 16, 2014 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 11-digit format for NDC 0378-3340-32?

    The 11-digit format is 00378334032. 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 4-4-2 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
    4-4-20378-3340-325-4-200378-3340-32