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  5. NDC Package Code: 68382-323-04 Estradiol

NDC Package 68382-323-04 Estradiol

Patch 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:
68382-323-04
Package Description:
4 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (68382-323-01) / 7 d in 1 PATCH
Product Code:
68382-323
Proprietary Name:
Estradiol
Non-Proprietary Name:
Estradiol
Substance Name:
Estradiol
Usage Information:
This medication is a female hormone. It is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). These symptoms are caused by the body making less estrogen. If you are using this medication to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected. Certain estrogen products may also be used by women after menopause to prevent bone loss (osteoporosis). However, there are other medications (such as raloxifene, bisphosphonates including alendronate) that are also effective in preventing bone loss and may be safer. These medications should be considered for use before estrogen treatment. Certain estrogen products may also be used by men and women to treat cancers (certain types of prostate cancer, breast cancer that has spread to other parts of the body) and by women who are not able to produce enough estrogen (for example, due to hypogonadism, primary ovarian failure).
11-Digit NDC Billing Format:
68382032304
NDC to RxNorm Crosswalk:
  • RxCUI: 476545 - estradiol 14 MCG/Day Weekly Transdermal System
  • RxCUI: 476545 - 168 HR estradiol 0.000583 MG/HR Transdermal System
  • RxCUI: 476545 - estradiol 0.000583 MG/HR Weekly Transdermal Patch
  • RxCUI: 476545 - estradiol 14 MCG/Day Weekly Transdermal Patch
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Zydus Pharmaceuticals Usa 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):
  • ESTRADIOL .014 mg/d
    • Pharmacologic Class(es):
  • Estradiol Congeners - [CS]
  • Estrogen Receptor Agonists - [MoA] (Mechanism of Action)
  • Estrogen - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA204379
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-02-2023
    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 68382-323-04?

    The NDC Packaged Code 68382-323-04 is assigned to a package of 4 pouch in 1 carton / 1 patch in 1 pouch (68382-323-01) / 7 d in 1 patch of Estradiol, a human prescription drug labeled by Zydus Pharmaceuticals Usa Inc.. The product's dosage form is patch and is administered via transdermal form.

    Is NDC 68382-323 included in the NDC Directory?

    Yes, Estradiol with product code 68382-323 is active and included in the NDC Directory. The product was first marketed by Zydus Pharmaceuticals Usa Inc. on November 02, 2023 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 11-digit format for NDC 68382-323-04?

    The 11-digit format is 68382032304. 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 5-3-2 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
    5-3-268382-323-045-4-268382-0323-04