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  5. NDC Package Code: 68968-0514-8 Combipatch (estradiol/norethindrone Acetate Transdermal System)

NDC Package 68968-0514-8 Combipatch (estradiol/norethindrone Acetate Transdermal System)

Estradiol/norethindrone Acetate Transdermal System Patch, Extended Release Transdermal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
68968-0514-8
Package Description:
8 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 3.5 d in 1 PATCH
Product Code:
68968-0514
Proprietary Name:
Combipatch (estradiol/norethindrone Acetate Transdermal System)
Non-Proprietary Name:
Estradiol/norethindrone Acetate Transdermal System
Substance Name:
Estradiol; Norethindrone Acetate
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.
11-Digit NDC Billing Format:
68968051408
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Noven Therapeutics, Llc
    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(s):
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
    • Active Ingredient(s):
  • ESTRADIOL .05 mg/d
  • NORETHINDRONE ACETATE .14 mg/d
    • Pharmacologic Class(es):
  • Estradiol Congeners - [CS]
  • Estrogen Receptor Agonists - [MoA] (Mechanism of Action)
  • Estrogen - [EPC] (Established Pharmacologic Class)
  • Progesterone Congeners - [CS]
  • Progestin - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    NDA020870
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-07-1998
    Listing Expiration Date:
    12-31-2025
    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.

    Frequently Asked Questions

    What is NDC 68968-0514-8?

    The NDC Packaged Code 68968-0514-8 is assigned to a 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. The product's dosage form is patch, extended release and is administered via transdermal form.

    Is NDC 68968-0514 included in the NDC Directory?

    Yes, Combipatch (estradiol/norethindrone Acetate Transdermal System) with product code 68968-0514 is active and included in the NDC Directory. The product was first marketed by Noven Therapeutics, Llc on August 07, 1998 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 68968-0514-8?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 68968-0514-8?

    The 11-digit format is 68968051408. 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 5-4-1 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
    5-4-168968-0514-85-4-268968-0514-08