Elestrin Gel, Metered
NDC Package 0037-4801-70

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

Package Information

Elestrin (estradiol) gel is a medication a female hormone (estrogen). This formulation utilizes a gel, metered delivery system. Marketed by Viatris Specialty Llc, this product is identified by NDC 0037-4801 and is authorized under FDA application NDA021813.

Identification & Billing

NDC Package Code
0037-4801-70
Package Description
2 BOTTLE, PUMP in 1 CARTON / 35 g in 1 BOTTLE, PUMP (0037-4801-35)
Product Code
0037-4801
11-Digit Billing Format
00037480170
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
35 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Elestrin
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 .52 mg/.87g
Pharmacologic Class
Usage Information
This medication is a female hormone (estrogen). It is absorbed through the skin and enters into the bloodstream. It is used by women to help reduce a certain symptom of menopause (hot flashes). Certain brands may also help to reduce vaginal symptoms of menopause (such as vaginal dryness/burning/itching). 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.

Regulatory & Marketing

Labeler Name
Viatris Specialty Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021813
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-02-2014
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 0037-4801-70 identifies a specific commercial package of 2 bottle, pump in 1 carton / 35 g in 1 bottle, pump (0037-4801-35) of Elestrin, a human prescription drug labeled by Viatris Specialty 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 Viatris Specialty Llc on June 02, 2014. 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 absorbed through the skin and enters into the bloodstream. It is used by women to help reduce a certain symptom of menopause (hot flashes). Certain brands may also help to reduce vaginal symptoms of menopause (such as vaginal dryness/burning/itching). 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.

How is this Viatris Specialty Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00037480170. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 35 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 (4-4-2)
0037-4801-70
11-Digit CMS (5-4-2)
00037-4801-70

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