NDC Package 54868-4920-0 Vivelle Dot

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing certification is expired.

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:
54868-4920-0
Package Description:
8 POUCH in 1 PACKET / 1 PATCH in 1 POUCH / 3.5 d in 1 PATCH
Product Code:
Proprietary Name:
Vivelle Dot
Usage Information:
Vivelle-Dot® (estradiol transdermal system) is indicated in:Treatment of moderate to severe vasomotor symptoms associated with the menopause. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.Treatment of hypoestrogenism due to hypogonadism, castration, or primary ovarian failure.Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.       The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
11-Digit NDC Billing Format:
54868492000
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 1149632 - estradiol 0.075 MG/Day Twice Weekly Transdermal System
  • RxCUI: 1149632 - 84 HR estradiol 0.00313 MG/HR Transdermal System
  • RxCUI: 1149632 - estradiol 0.00313 MG/HR 84 HR Transdermal Patch
  • RxCUI: 1149632 - estradiol 75 MCG/Day Twice Weekly Transdermal Patch
  • RxCUI: 1149634 - Vivelle dot 0.075 MG/Day Twice Weekly Transdermal System
  • Labeler Name:
    Physicians Total Care, Inc.
    Sample Package:
    No
    Start Marketing Date:
    09-23-2003
    Listing Expiration Date:
    12-31-2017
    Exclude Flag:
    E
    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 54868-4920-0?

    The NDC Packaged Code 54868-4920-0 is assigned to a package of 8 pouch in 1 packet / 1 patch in 1 pouch / 3.5 d in 1 patch of Vivelle Dot, labeled by Physicians Total Care, Inc.. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 54868-4920 included in the NDC Directory?

    No, Vivelle Dot with product code 54868-4920 is excluded from the NDC Directory for failure to respond to FDA's requests for correction to deficient or non-compliant submissions. The product was first marketed by Physicians Total Care, Inc. on September 23, 2003 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 54868-4920-0?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 54868-4920-0?

    The 11-digit format is 54868492000. 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 5-4-1 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
    5-4-154868-4920-05-4-254868-4920-00