NDC Package 54868-5286-0 Nortrel 7/7/7 (28 Day Regimen)

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:

54868-5286-0

Package Description:

1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Product Code:

54868-5286

Proprietary Name:

Nortrel 7/7/7 (28 Day Regimen)

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

11-Digit NDC Billing Format:

54868528600

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: 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

Labeler Name:

Physicians Total Care, Inc.

Sample Package:

Start Marketing Date:

08-19-2008

Listing Expiration Date:

12-31-2017

Exclude Flag:

Code Structure:

54868 - Physicians Total Care, Inc.
- 54868-5286 - Nortrel 7/7/7
  - 54868-5286-0 - 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

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 54868-5286-0?

The NDC Packaged Code 54868-5286-0 is assigned to a 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.. 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 54868-5286 included in the NDC Directory?

No, Nortrel 7/7/7 (28 Day Regimen) with product code 54868-5286 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Physicians Total Care, Inc. on August 19, 2008 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 54868-5286-0?

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 54868-5286-0?

The 11-digit format is 54868528600. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-4-1	54868-5286-0	5-4-2	54868-5286-00

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