Estradiol / Norethindrone Acetate
NDC Package 54868-4677-0

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 inactivated by the FDA.

Estradiol / Norethindrone Acetate is estradiol/Norethindrone Acetate Tablets 1.0 mg/0.5 mg and 0.5 mg/0.1 mg are indicated in women who have a uterus for the:Treatment of moderate to severe vasomotor symptoms associated with menopause.Prevention of postmenopausal osteoporosis. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4677 and is authorized under FDA application ANDA078324.

Identification & Billing

NDC Package Code
54868-4677-0
Package Description
1 BLISTER PACK in 1 CARTON / 28 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
54868-4677
11-Digit Billing Format
54868467700
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: 1359126 - estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet
  • RxCUI: 1359127 - {28 (estradiol 1 MG / norethindrone acetate 0.5 MG Oral Tablet) } Pack
  • RxCUI: 1359127 - Estra-Noreth Ac 1-0.5 MG (28) Oral Tablet 28 Day Pack

Clinical Specifications

Proprietary Name
Estradiol / Norethindrone Acetate
Dosage Form
-
Usage Information
Estradiol/Norethindrone Acetate Tablets 1.0 mg/0.5 mg and 0.5 mg/0.1 mg are indicated in women who have a uterus for the:Treatment of moderate to severe vasomotor symptoms associated with menopause.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.Estradiol/Norethindrone Acetate Tablets 1.0 mg/0.5 mg is also indicated in women who have a uterus for the:3. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause. When used solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA078324
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-10-2010
Listing Expiration
12-31-2017
Exclude Flag
I
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 54868-4677-0 identifies a specific commercial package of 1 blister pack in 1 carton / 28 tablet, film coated in 1 blister pack of Estradiol / Norethindrone Acetate, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Physicians Total Care, Inc. on March 10, 2010. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868467700. 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 (5-4-1)
54868-4677-0
11-Digit CMS (5-4-2)
54868-4677-00

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