Xulane Patch
NDC Package 0378-3340-53

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Xulane (norelgestromin and ethinyl estradiol) patches is this patch contains combination hormone medication and is used to prevent pregnancy. This formulation utilizes a patch delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-3340 and is authorized under FDA application ANDA200910.

Identification & Billing

NDC Package Code
0378-3340-53
Package Description
3 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (0378-3340-16) / 7 d in 1 PATCH
Product Code
0378-3340
11-Digit Billing Format
00378334053
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
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]

Clinical Specifications

Proprietary Name
Xulane
Non-Proprietary Name
Norelgestromin And Ethinyl Estradiol
Substance Name
Ethinyl Estradiol; Norelgestromin
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
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
Pharmacologic Class
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).

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA200910
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-16-2014
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0378-3340-53 identifies a specific commercial package of 3 pouch in 1 carton / 1 patch in 1 pouch (0378-3340-16) / 7 d in 1 patch of Xulane, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This patch is formulated for transdermal use and contains ethinyl estradiol; norelgestromin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Mylan Pharmaceuticals Inc. on April 16, 2014. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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).

How is this Mylan Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378334053. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0378-3340-53
11-Digit CMS (5-4-2)
00378-3340-53

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.