Evamist Spray
NDC Package 0574-2067-00

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

Evamist (estradiol) sprays is a medication a female hormone (estrogen). This formulation utilizes a spray delivery system. Marketed by Padagis Us Llc, this product is identified by NDC 0574-2067 and is authorized under FDA application NDA022014.

Identification & Billing

NDC Package Code
0574-2067-00
Package Description
56 SPRAY in 1 VIAL, MULTI-DOSE
Product Code
0574-2067
11-Digit Billing Format
00574206700
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Evamist
Non-Proprietary Name
Estradiol
Substance Name
Estradiol
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
Active Ingredient(s)
ESTRADIOL 1.53 mg/1
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). Symptoms of menopause are caused by the body making less estrogen. If you are using estrogens to treat only vaginal symptoms of menopause (such as vaginal dryness/burning/itching), 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
Padagis Us Llc
Product Type
Human Prescription Drug
FDA Application #
NDA022014
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-11-2015
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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 (0574-2067). Click a package code to view its specific billing and regulatory data.

0574-2067-27
56 SPRAY in 1 VIAL, MULTI-DOSE

* 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 0574-2067-00 identifies a specific commercial package of 56 spray in 1 vial, multi-dose of Evamist, a human prescription drug labeled by Padagis Us Llc. This spray is formulated for transdermal 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 Padagis Us Llc on April 11, 2015. 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). Symptoms of menopause are caused by the body making less estrogen. If you are using estrogens to treat only vaginal symptoms of menopause (such as vaginal dryness/burning/itching), 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 Padagis Us Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00574206700. 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)
0574-2067-00
11-Digit CMS (5-4-2)
00574-2067-00

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