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  5. NDC Package Code: 63539-122-07 Duavee

NDC Package 63539-122-07 Duavee

Conjugated Estrogens/bazedoxifene Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
63539-122-07
Package Description:
1 BLISTER PACK in 1 CARTON / 7 TABLET, FILM COATED in 1 BLISTER PACK
Product Code:
63539-122
Proprietary Name:
Duavee
Non-Proprietary Name:
Conjugated Estrogens/bazedoxifene
Substance Name:
Bazedoxifene Acetate; Estrogens, Conjugated
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.
11-Digit NDC Billing Format:
63539012207
NDC to 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]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    U.s. Pharmaceuticals
    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):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • BAZEDOXIFENE ACETATE 20 mg/1
  • ESTROGENS, CONJUGATED .45 mg/1
    • Pharmacologic Class(es):
  • Estrogen Agonist/Antagonist - [EPC] (Established Pharmacologic Class)
  • Estrogen Receptor Agonists - [MoA] (Mechanism of Action)
  • Estrogen - [EPC] (Established Pharmacologic Class)
  • Estrogens, Conjugated (USP) - [CS]
  • Selective Estrogen Receptor Modulators - [MoA] (Mechanism of Action)
    • Sample Package:
    Yes
    FDA Application Number:
    NDA022247
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    11-15-2013
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 63539-122-07?

    The NDC Packaged Code 63539-122-07 is assigned to a package of 1 blister pack in 1 carton / 7 tablet, film coated in 1 blister pack of Duavee, a human prescription drug labeled by U.s. Pharmaceuticals. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 63539-122 included in the NDC Directory?

    Yes, Duavee with product code 63539-122 is active and included in the NDC Directory. The product was first marketed by U.s. Pharmaceuticals on November 15, 2013 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 63539-122-07?

    The 11-digit format is 63539012207. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-263539-122-075-4-263539-0122-07