Nortrel 7/7/7
NDC Package 54868-5286-0

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.

Nortrel 7/7/7 is nortrel™ 7/7/7 (norethindrone and ethinyl estradiol tablets, USP 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg) (21 Day Regimen and 28 Day Regimen) are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.Oral contraceptives are highly effective. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-5286 and is authorized under FDA application ANDA075478.

Identification & Billing

NDC Package Code
54868-5286-0
Package Description
1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
Product Code
54868-5286
11-Digit Billing Format
54868528600
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: 310463 - norethindrone 0.5 MG / ethinyl estradiol 0.035 MG Oral Tablet
  • RxCUI: 310463 - ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet
  • RxCUI: 310463 - ethinyl estradiol 35 MCG / norethindrone 0.5 MG Oral Tablet
  • RxCUI: 312033 - norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral Tablet
  • RxCUI: 312033 - ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet

Clinical Specifications

Proprietary Name
Nortrel 7/7/7 (28 Day Regimen)
Dosage Form
-
Usage Information
Nortrel™ 7/7/7 (norethindrone and ethinyl estradiol tablets, USP 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg) (21 Day Regimen and 28 Day Regimen) are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.TABLE I: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR. UNITED STATESAdapted from Hatcher et al., 1998 Ref. #1.% of Women Experiencing an Unintended Pregnancy within the First Year of Use% of Women Continuing Use at One Year Method (1) Typical Use (2)Perfect Use (3)(4)Chance 8585Spermicides 26640Periodic abstinence 2563Calendar 9Ovulation Method 3Sympto-Thermal 2Post-Ovulation1Withdrawal 194Cap With spermicidal cream or jelly.Parous Women 402642Nulliparous Women 20956SpongeParous Women 402042Nulliparous Women 20956Diaphragm 20656Condom Female (Reality) 21556Male 14361Pill 571Progestin Only 0.5Combined 0.1IUDProgesterone T 2.01.581Copper T380A 0.80.678LNg 20 0.10.181Depo-Provera 0.30.370Norplant and Norplant-2 0.050.0588Female Sterilization 0.50.5100Male Sterilization 0.150.10100

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA075478
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-19-2008
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 54868-5286-0 identifies a specific commercial package of 1 blister pack in 1 pouch / 1 kit in 1 blister pack of Nortrel 7/7/7 (28 Day Regimen), 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 August 19, 2008. 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: 54868528600. 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)
54868-5286-0
11-Digit CMS (5-4-2)
54868-5286-00

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