Estrogel Gel, Metered
NDC Package 17139-617-20

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

Package Information

Estrogel (estradiol) gel is a medication a female hormone (estrogen). This formulation utilizes a gel, metered delivery system. Marketed by Ascend Therapeutics Us, Llc, this product is identified by NDC 17139-617 and is authorized under FDA application NDA021166.

Identification & Billing

NDC Package Code
17139-617-20
Package Description
25 g in 1 BOTTLE, PUMP
Product Code
17139-617
11-Digit Billing Format
17139061720
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Estrogel
Non-Proprietary Name
Estradiol
Substance Name
Estradiol
Dosage Form
Gel, Metered - A gel preparation, with metered dose valves, which allow for the delivery of a uniform quantity of gel upon each activation.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
ESTRADIOL .75 mg/1.25g
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
Ascend Therapeutics Us, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021166
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-09-2004
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (17139-617). Click a package code to view its specific billing and regulatory data.

17139-617-40
50 g in 1 BOTTLE, PUMP
17139-617-43
3 BOTTLE, PUMP in 1 CARTON / 50 g in 1 BOTTLE, PUMP

* 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 17139-617-20 identifies a specific commercial package of 25 g in 1 bottle, pump of Estrogel, a human prescription drug labeled by Ascend Therapeutics Us, Llc. This gel, metered is formulated for topical 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 Ascend Therapeutics Us, Llc on February 09, 2004. The current certification is valid through December 31, 2027.

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 Ascend Therapeutics Us, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 17139061720. 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 (5-3-2)
17139-617-20
11-Digit CMS (5-4-2)
17139-0617-20

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