Duavee Tablet, Film Coated
NDC 63539-122

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 63539-122?
  5. Duavee Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Duavee (conjugated estrogens/bazedoxifene) is a NDA-approved product labeled by U.s. Pharmaceuticals. This medication is a combination product containing conjugated estrogens and bazedoxifene (an estrogen agonist/antagonist). It is supplied as a pink tablet, film coated for oral administration. This product entry covers the primary NDC 63539-122 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
63539-122
Proprietary Name:
Duavee
Non-Proprietary Name: [1]
Conjugated Estrogens/bazedoxifene
Substance Name: [2]
Bazedoxifene Acetate; Estrogens, Conjugated
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
U.s. Pharmaceuticals
Labeler Code:
63539
Product Label ID:
e16705d8-4472-4f83-96ac-69fa2be066cb
FDA Application Number: [6]
NDA022247
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
11-15-2013
End Marketing Date: [10]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
PINK (C48328 - PINK)
Shape:
OVAL (C48345)
Size(s):
12 MM
Imprint(s):
045;20
Score:
1

Code Structure Chart

Product Details

What is NDC 63539-122?

The NDC code 63539-122 is assigned by the FDA to the product Duavee. It is commonly known by its generic name, conjugated estrogens/bazedoxifene. This pharmaceutical product is labeled by U.s. Pharmaceuticals and is currently categorized as listed product. The medication is a tablet, film coated administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 63539-122-07. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • BAZEDOXIFENE ACETATE 20 mg/1
  • ESTROGENS, CONJUGATED .45 mg/1 - A pharmaceutical preparation containing a mixture of water-soluble, conjugated estrogens derived wholly or in part from URINE of pregnant mares or synthetically from ESTRONE and EQUILIN. It contains a sodium-salt mixture of estrone sulfate (52-62%) and equilin sulfate (22-30%) with a total of the two between 80-88%. Other concomitant conjugates include 17-alpha-dihydroequilin, 17-alpha-estradiol, and 17-beta-dihydroequilin. The potency of the preparation is expressed in terms of an equivalent quantity of sodium estrone sulfate.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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]

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Estrogen and Bazedoxifene


Estrogen and bazedoxifene tablets are used to treat hot flashes (sudden feelings of warmth, especially in the face, neck, and chest) in women who are experiencing menopause (stage of life when menstrual periods become less frequent and stop and women may experience other symptoms and body changes). Estrogen and bazedoxifene tablets are also used to prevent osteoporosis (condition in which the bones become thin and weak and break easily) in women who have undergone menopause. Estrogen is in a class of medications called hormones and bazedoxifene is in a class of medications called estrogen agonist–antagonists. Estrogen works by replacing estrogen that is normally produced by the body. Bazedoxifene is used to block the action of estrogen on the lining of the uterus, decreasing the risk of overgrowth that may lead to cancer.
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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".