Combipatch (estradiol/norethindrone Acetate Transdermal System) Patch, Extended Release
NDC Package 68968-0525-8

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

Package Information

Combipatch (estradiol/norethindrone Acetate Transdermal System) (estradiol/norethindrone acetate transdermal system) patches is combiPatch is indicated in a woman with a uterus for:Treatment of moderate to severe vasomotor symptoms due to menopause.Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. This formulation utilizes a patch, extended release delivery system. Marketed by Noven Therapeutics, Llc, this product is identified by NDC 68968-0525 and is authorized under FDA application NDA020870.

Identification & Billing

NDC Package Code
68968-0525-8
Package Description
8 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 3.5 d in 1 PATCH
Product Code
68968-0525
11-Digit Billing Format
68968052508
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: 1251493 - estradiol 50 MCG / norethindrone acetate 140 MCG/Day Twice Weekly Transdermal System
  • RxCUI: 1251493 - 84 HR estradiol 0.00208 MG/HR / norethindrone acetate 0.00583 MG/HR Transdermal System
  • RxCUI: 1251493 - estradiol 0.00208 MG / norethindrone acetate 0.00583 MG per HR 84 HR Transdermal Patch
  • RxCUI: 1251493 - estradiol 0.05 MG / norethindrone acetate 0.14 MG per Day Twice Weekly Transdermal Patch
  • RxCUI: 1251495 - Combipatch 50/140 MCG/Day Twice Weekly Transdermal System

Clinical Specifications

Proprietary Name
Combipatch (estradiol/norethindrone Acetate Transdermal System)
Non-Proprietary Name
Estradiol/norethindrone Acetate Transdermal System
Substance Name
Estradiol; Norethindrone Acetate
Dosage Form
Patch, Extended Release - A drug delivery system in the form of a patch that releases the drug in such a manner that a reduction in dosing frequency compared to that drug presented as a conventional dosage form (e.g., a solution or a prompt drug-releasing, conventional solid dosage form).
Administration Route
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
Pharmacologic Class
Usage Information
CombiPatch is indicated in a woman with a uterus for:Treatment of moderate to severe vasomotor symptoms due to menopause.Treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.

Regulatory & Marketing

Labeler Name
Noven Therapeutics, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA020870
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-07-1998
Listing Expiration
12-31-2026
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 68968-0525-8 identifies a specific commercial package of 8 pouch in 1 carton / 1 patch in 1 pouch / 3.5 d in 1 patch of Combipatch (estradiol/norethindrone Acetate Transdermal System), a human prescription drug labeled by Noven Therapeutics, Llc. This patch, extended release is formulated for transdermal use and contains estradiol; norethindrone acetate 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 Noven Therapeutics, Llc on August 07, 1998. The current certification is valid through December 31, 2026.

How is this Noven Therapeutics, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68968052508. 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 (5-4-1)
68968-0525-8
11-Digit CMS (5-4-2)
68968-0525-08

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