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  5. NDC Package Code: 47781-104-44 Estradiol

NDC Package 47781-104-44 Estradiol

Cream Vaginal - 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:
47781-104-44
Package Description:
1 TUBE, WITH APPLICATOR in 1 CARTON / 42.5 g in 1 TUBE, WITH APPLICATOR
Product Code:
47781-104
Proprietary Name:
Estradiol
Non-Proprietary Name:
Estradiol
Substance Name:
Estradiol Hemihydrate
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:
47781010444
Billing Unit:
GM - Billing unit of "gram" is used when a product is measured by its weight.
NDC to RxNorm Crosswalk:
42.5 GM
NDC to RxNorm Crosswalk:
  • RxCUI: 310169 - estradiol 0.01 % Vaginal Cream
  • RxCUI: 310169 - estradiol 0.1 MG/ML Vaginal Cream
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Alvogen Inc.
    Dosage Form:
    Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
    Administration Route(s):
  • Vaginal - Administration into the vagina.
    • Active Ingredient(s):
  • ESTRADIOL HEMIHYDRATE .1 mg/g
    • Pharmacologic Class(es):
  • Estradiol Congeners - [CS]
  • Estrogen Receptor Agonists - [MoA] (Mechanism of Action)
  • Estrogen - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA209767
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-05-2018
    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.

    Frequently Asked Questions

    What is NDC 47781-104-44?

    The NDC Packaged Code 47781-104-44 is assigned to a package of 1 tube, with applicator in 1 carton / 42.5 g in 1 tube, with applicator of Estradiol, a human prescription drug labeled by Alvogen Inc.. The product's dosage form is cream and is administered via vaginal form.

    Is NDC 47781-104 included in the NDC Directory?

    Yes, Estradiol with product code 47781-104 is active and included in the NDC Directory. The product was first marketed by Alvogen Inc. on March 05, 2018 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 NDC billing unit for package 47781-104-44?

    The contents of this package are billed per "gm or gram", products billed per gram are products measured by weight. The calculated billable units for this package is 42.5.

    What is the 11-digit format for NDC 47781-104-44?

    The 11-digit format is 47781010444. 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
    5-3-247781-104-445-4-247781-0104-44