Estradiol Gel, Metered
NDC Package 70954-646-10

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings

Package Information

Estradiol gel is a medication a female hormone. This formulation utilizes a gel, metered delivery system. Marketed by Ani Pharmaceuticals, Inc., this product is identified by NDC 70954-646 and is authorized under FDA application ANDA217882.

Identification & Billing

NDC Package Code
70954-646-10
Package Description
50 g in 1 BOTTLE, PUMP
Product Code
11-Digit Billing Format
70954064610
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
50 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Estradiol
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)
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).

Regulatory & Marketing

Labeler Name
Ani Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA217882
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-23-2024
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 70954-646-10 identifies a specific commercial package of 50 g in 1 bottle, pump of Estradiol, a human prescription drug labeled by Ani Pharmaceuticals, Inc.. 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 Ani Pharmaceuticals, Inc. on October 23, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

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).

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70954064610. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 50 total billable units per package. 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)
70954-646-10
11-Digit CMS (5-4-2)
70954-0646-10

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