Duavee
NDC Package 63539-112-07

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Duavee is a medication a combination product containing conjugated estrogens and bazedoxifene (an estrogen agonist/antagonist). Marketed by U.s. Pharmaceuticals, this product is identified by NDC 63539-112 and is authorized under FDA application NDA022247.

Identification & Billing

NDC Package Code
63539-112-07
Package Description
1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
63539-112
11-Digit Billing Format
63539011207

Clinical Specifications

Proprietary Name
Duavee
Dosage Form
-
Usage Information
This medication is a combination product containing conjugated estrogens and bazedoxifene (an estrogen agonist/antagonist). It is used by women with a uterus to help reduce symptoms of menopause (such as hot flashes, vaginal dryness) and to prevent bone loss (osteoporosis) after menopause. Conjugated estrogens are female hormones which help to decrease menopausal symptoms caused by the body making less estrogen. Bazedoxifene is not a hormone, but works by acting like estrogen (as a selective estrogen receptor modulator or SERM) in some parts of the body. The bazedoxifene in this medication helps to preserve bone mass and reduces the risk of cancer of the uterus which can be caused by using estrogen. If you are using this medication to treat symptoms only in and around the vagina, consider using products applied directly inside the vagina instead of medications that are taken by mouth, absorbed through the skin, or injected.

Regulatory & Marketing

Labeler Name
U.s. Pharmaceuticals
FDA Application #
NDA022247
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-15-2013
End Marketing Date
11-15-2013
Listing Expiration
11-15-2013
Exclude Flag
D
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 63539-112-07 identifies a specific commercial package of 1 blister pack in 1 carton / 7 tablet, film coated in 1 blister pack of Duavee, labeled by U.s. Pharmaceuticals. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by U.s. Pharmaceuticals on November 15, 2013. The current certification is valid through November 15, 2013.

What are the primary indications for this medication?

This medication is a combination product containing conjugated estrogens and bazedoxifene (an estrogen agonist/antagonist). It is used by women with a uterus to help reduce symptoms of menopause (such as hot flashes, vaginal dryness) and to prevent bone loss (osteoporosis) after menopause. Conjugated estrogens are female hormones which help to decrease menopausal symptoms caused by the body making less estrogen. Bazedoxifene is not a hormone, but works by acting like estrogen (as a selective estrogen receptor modulator or SERM) in some parts of the body. The bazedoxifene in this medication helps to preserve bone mass and reduces the risk of cancer of the uterus which can be caused by using estrogen. If you are using this medication to treat symptoms only in and around the vagina, consider using products applied directly inside the vagina instead of medications that are taken by mouth, absorbed through the skin, or injected.

How is this U.s. Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63539011207. 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)
63539-112-07
11-Digit CMS (5-4-2)
63539-0112-07

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