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  5. NDC Package Code: 45802-097-35 Estradiol Vaginal

NDC Package 45802-097-35 Estradiol Vaginal

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:
45802-097-35
Package Description:
1 TUBE in 1 CARTON / 42.5 g in 1 TUBE
Product Code:
45802-097
Proprietary Name:
Estradiol Vaginal
Non-Proprietary Name:
Estradiol
Substance Name:
Estradiol
Usage Information:
This medication is a female hormone (estrogen). 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. This medication may also be used by women who are not able to produce enough estrogen (for example, due to hypogonadism, primary ovarian failure). 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.
11-Digit NDC Billing Format:
45802009735
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:
    Padagis Israel Pharmaceuticals Ltd
    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 .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:
    ANDA210194
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-06-2021
    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 45802-097-35?

    The NDC Packaged Code 45802-097-35 is assigned to a package of 1 tube in 1 carton / 42.5 g in 1 tube of Estradiol Vaginal, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. The product's dosage form is cream and is administered via vaginal form.

    Is NDC 45802-097 included in the NDC Directory?

    Yes, Estradiol Vaginal with product code 45802-097 is active and included in the NDC Directory. The product was first marketed by Padagis Israel Pharmaceuticals Ltd on January 06, 2021 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 45802-097-35?

    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 45802-097-35?

    The 11-digit format is 45802009735. 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
    5-3-245802-097-355-4-245802-0097-35