Duavee Tablet, Film Coated
NDC Package 0008-1123-12

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

Package Information

Duavee (conjugated estrogens/bazedoxifene) tablets is a medication a combination product containing conjugated estrogens and bazedoxifene (an estrogen agonist/antagonist). This formulation utilizes a tablet, film coated delivery system. Marketed by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc., this product is identified by NDC 0008-1123 and is authorized under FDA application NDA022247.

Identification & Billing

NDC Package Code
0008-1123-12
Package Description
1 POUCH in 1 CARTON / 2 BLISTER PACK in 1 POUCH / 15 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
0008-1123
11-Digit Billing Format
00008112312
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 1441392 - estrogens, conjugated 0.45 MG / bazedoxifene acetate 20 MG Oral Tablet
  • RxCUI: 1441392 - bazedoxifene 20 MG / estrogens, conjugated (USP) 0.45 MG Oral Tablet
  • RxCUI: 1441392 - bazedoxifene 20 MG (as bazedoxifene acetate 22.6 MG) / estrogens, conjugated (USP) 0.45 MG Oral Tablet
  • RxCUI: 1441740 - Duavee 0.45 MG / 20 MG Oral Tablet
  • RxCUI: 1441740 - bazedoxifene 20 MG / estrogens, conjugated (USP) 0.45 MG Oral Tablet [Duavee]

Clinical Specifications

Proprietary Name
Duavee
Non-Proprietary Name
Conjugated Estrogens/bazedoxifene
Substance Name
Bazedoxifene Acetate; Estrogens, Conjugated
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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
Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022247
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
10-03-2013
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 0008-1123-12 identifies a specific commercial package of 1 pouch in 1 carton / 2 blister pack in 1 pouch / 15 tablet, film coated in 1 blister pack of Duavee, a human prescription drug labeled by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. This tablet, film coated is formulated for oral use and contains bazedoxifene acetate; estrogens, conjugated 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 Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc. on October 03, 2013. The current certification is valid through December 31, 2027.

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 Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00008112312. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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)
0008-1123-12
11-Digit CMS (5-4-2)
00008-1123-12

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