Estradiol Vaginal Cream
NDC Package 68071-3796-4

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

Package Information

Estradiol Vaginal (estradiol) cream is a medication a female hormone (estrogen). This formulation utilizes a cream delivery system. Marketed by Nucare Pharmaceuticals, Inc., this product is identified by NDC 68071-3796 and is authorized under FDA application ANDA210194.

Identification & Billing

NDC Package Code
68071-3796-4
Package Description
1 TUBE in 1 CARTON / 42.5 g in 1 TUBE
Product Code
68071-3796
11-Digit Billing Format
68071379604
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Estradiol Vaginal
Non-Proprietary Name
Estradiol
Substance Name
Estradiol
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
Vaginal - Administration into the vagina.
Active Ingredient(s)
ESTRADIOL .1 mg/g
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Nucare Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA210194
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-06-2021
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 68071-3796-4 identifies a specific commercial package of 1 tube in 1 carton / 42.5 g in 1 tube of Estradiol Vaginal, a human prescription drug labeled by Nucare Pharmaceuticals, Inc.. This cream is formulated for vaginal use and contains estradiol 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 Nucare Pharmaceuticals, Inc. on January 06, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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.

How is this Nucare Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68071379604. 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)
68071-3796-4
11-Digit CMS (5-4-2)
68071-3796-04

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