NDC Package 0555-9012-58 Nortrel 7/7/7 (28 Day Regimen)

Norethindrone And Ethinyl Estradiol Kit - View Billable Units, 11-Digit Format, RxNorm

Package Information
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:

0555-9012-58

Package Description:

6 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (0555-9012-79) / 1 KIT in 1 BLISTER PACK

Product Code:

0555-9012

Proprietary Name:

Nortrel 7/7/7 (28 Day Regimen)

Non-Proprietary Name:

Norethindrone And Ethinyl Estradiol

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) is 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 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and the NORPLANT® System depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.Table 1: 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 States. % of Women Experiencing an Unintended Pregnancy within the First Year of Use% of Women Continuing Use at One Year Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year. Method (1) Typical Use Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.(2)Perfect Use Among couples who initiate use of a method (not necessarily for the first time), and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.(3)(4)Chance The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether. 8585Spermicides Foams, creams, gels, vaginal suppositories, and vaginal film.26640Periodic abstinence 2563 Calendar 9 Ovulation Method 3 Sympto-Thermal Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases. 2 Post-Ovulation1Cap With spermicidal cream or jelly. Parous Women 402642 Nulliparous Women 20956Sponge Parous Women 402042 Nulliparous Women 20956Diaphragm 20656Withdrawal 194Condom Without spermicides. Female (Reality®) 21556 Male 14361Pill 571 Progestin Only 0.5 Combined 0.1IUD Progesterone T 2.01.581 Copper T380A 0.80.678 LNg 20 0.10.181Depo-Provera®0.30.370Norplant® and Norplant-2®0.050.0588Female Sterilization 0.50.5100Male Sterilization 0.150.10100Adapted from Hatcher et al., 1998, Ref. #1.Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral® (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 2 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills).Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches six months of age.Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York, NY: Irvington Publishers, 1998.Nortrel 7/7/7 has not been studied for and is not indicated for use in emergency contraception.

11-Digit NDC Billing Format:

00555901258

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

6 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

Product Type:

Human Prescription Drug

Labeler Name:

Teva Pharmaceuticals Usa, Inc.

Dosage Form:

Kit - A packaged collection of related material.

Sample Package:

FDA Application Number:

ANDA075478

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

01-02-2003

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

0555 - Teva Pharmaceuticals Usa, Inc.
- 0555-9012 - Nortrel 7/7/7
  - 0555-9012-58 - 6 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (0555-9012-79) / 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 0555-9012-58?

The NDC Packaged Code 0555-9012-58 is assigned to a package of 6 pouch in 1 carton / 1 blister pack in 1 pouch (0555-9012-79) / 1 kit in 1 blister pack of Nortrel 7/7/7 (28 Day Regimen), a human prescription drug labeled by Teva Pharmaceuticals Usa, Inc.. The product's dosage form is kit and is administered via form.

Is NDC 0555-9012 included in the NDC Directory?

Yes, Nortrel 7/7/7 (28 Day Regimen) with product code 0555-9012 is active and included in the NDC Directory. The product was first marketed by Teva Pharmaceuticals Usa, Inc. on January 02, 2003 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 NDC billing unit for package 0555-9012-58?

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 6.

What is the 11-digit format for NDC 0555-9012-58?

The 11-digit format is 00555901258. 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 4-4-2 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0555-9012-58	5-4-2	00555-9012-58

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