Yuvafem Tablet
NDC Package 42291-962-18

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

Yuvafem (estradiol) tablets is a medication a female hormone (estrogen). This formulation utilizes a tablet delivery system. Marketed by Avkare, this product is identified by NDC 42291-962 and is authorized under FDA application ANDA205256.

Identification & Billing

NDC Package Code
42291-962-18
Package Description
18 APPLICATOR in 1 CARTON / 1 TABLET in 1 APPLICATOR (42291-962-11)
Product Code
42291-962
11-Digit Billing Format
42291096218
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
18 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Yuvafem
Non-Proprietary Name
Estradiol
Substance Name
Estradiol
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Vaginal - Administration into the vagina.
Active Ingredient(s)
ESTRADIOL 10 ug/1
Pharmacologic Class
Usage Information
This medication is a female hormone (estrogen). It is used by women to help reduce vaginal symptoms of menopause (such as vaginal dryness/burning/itching). These symptoms are caused by the body making less estrogen. When treating only vaginal symptoms of menopause, products applied directly inside the vagina (such as this medication) should be used first. Estrogens that are taken by mouth, absorbed through the skin, or injected may have greater risks of side effects due to more estrogen being absorbed.

Regulatory & Marketing

Labeler Name
Avkare
Product Type
Human Prescription Drug
FDA Application #
ANDA205256
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-19-2016
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 (42291-962). Click a package code to view its specific billing and regulatory data.

42291-962-08
8 APPLICATOR in 1 CARTON / 1 TABLET in 1 APPLICATOR (42291-962-11)

* 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 42291-962-18 identifies a specific commercial package of 18 applicator in 1 carton / 1 tablet in 1 applicator (42291-962-11) of Yuvafem, a human prescription drug labeled by Avkare. This product is billed for "EA" each discreet unit and contains an estimated amount of 18 billable units per package. This tablet is formulated for vaginal 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 Avkare on October 19, 2016. 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 vaginal symptoms of menopause (such as vaginal dryness/burning/itching). These symptoms are caused by the body making less estrogen. When treating only vaginal symptoms of menopause, products applied directly inside the vagina (such as this medication) should be used first. Estrogens that are taken by mouth, absorbed through the skin, or injected may have greater risks of side effects due to more estrogen being absorbed.

How is this Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291096218. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 18 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)
42291-962-18
11-Digit CMS (5-4-2)
42291-0962-18

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