Estradiol Gel
NDC Package 21922-090-52

11-digit billing NDC: 21922009052 · Billing unit: GM · 37.5 GM per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Estradiol Gel (estradiol) gel is estradiol gel 0.1% is contraindicated in women with any of the following conditions:    • Undiagnosed abnormal genital bleeding [see Warning and Precautions (5.2)]    • Breast cancer or history of breast cancer [see Warning and Precautions (5.2)]    • Estrogen-dependent neoplasia [see Warning and Precautions (5.2)]    • Active DVT, PE, or history of these conditions [see Warning and Precautions (5.1)]    • Active arterial thromboembolic disease (e.g., stroke and MI), or a history of these   conditions [see Warning and Precautions (5.1)]    • Known anaphylactic reaction, angioedema, or hypersensitivity to estradiol gel 0.1%    • Hepatic impairment or disease    • Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. This formulation utilizes a gel delivery system. Marketed by Encube Ethicals, Inc., this product is identified by NDC 21922-090 and is authorized under FDA application ANDA218507.

Identification & Billing

NDC Package Code
21922-090-52
Package Description
30 PACKET in 1 CARTON / 1.25 g in 1 PACKET
Product Code
21922-090
11-Digit Billing Format
21922009052
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
37.5 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Estradiol Gel
Non-Proprietary Name
Estradiol
Substance Name
Estradiol
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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 1.25 mg/1.25g
Pharmacologic Class
Usage Information
Estradiol gel 0.1% is contraindicated in women with any of the following conditions:    • Undiagnosed abnormal genital bleeding [see Warning and Precautions (5.2)]    • Breast cancer or history of breast cancer [see Warning and Precautions (5.2)]    • Estrogen-dependent neoplasia [see Warning and Precautions (5.2)]    • Active DVT, PE, or history of these conditions [see Warning and Precautions (5.1)]    • Active arterial thromboembolic disease (e.g., stroke and MI), or a history of these   conditions [see Warning and Precautions (5.1)]    • Known anaphylactic reaction, angioedema, or hypersensitivity to estradiol gel 0.1%    • Hepatic impairment or disease    • Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders

Regulatory & Marketing

Labeler Name
Encube Ethicals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA218507
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-10-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 21922-090-52 identifies a specific commercial package of 30 packet in 1 carton / 1.25 g in 1 packet of Estradiol Gel, a human prescription drug labeled by Encube Ethicals, Inc.. This gel 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 Encube Ethicals, Inc. on March 10, 2025. The current certification is valid through December 31, 2027.

How is this Encube Ethicals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21922009052. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 37.5 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)
21922-090-52
11-Digit CMS (5-4-2)
21922-0090-52

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