NDC Package 54868-4730-0 Ortho Tri Cyclen Lo

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:

54868-4730-0

Package Description:

1 KIT in 1 BLISTER PACK

Product Code:

54868-4730

Proprietary Name:

Ortho Tri Cyclen Lo

Usage Information:

ORTHO TRI-CYCLEN® Lo Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.In an active controlled clinical trial 1,673 subjects completed 11,003 cycles of ORTHO TRI-CYCLEN® Lo use and a total of 20 pregnancies were reported in ORTHO TRI-CYCLEN® Lo users.99 This represents an overall use-efficacy (typical user efficacy) pregnancy rate of 2.36 per 100 women-years of use.Oral contraceptives are highly effective for pregnancy prevention. Table 2 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, 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 2: 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 MethodTypical Use Perfect Use (1)(2)(3)(4)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 FDA 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 4 yellow pills).Lactation 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 6 months of age.Source: Trussell J. Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.Chance 8585Spermicides 26640Periodic abstinence2563 Calendar9 Ovulation Method3 Sympto-Thermal 2 Post-Ovulation1Withdrawal194CapWith spermicidal cream or jelly. Parous Women402642 Nulliparous Women20956Sponge Parous Women402042 Nulliparous Women20956Diaphragm20656Condom Female (Reality®)21556 Male14361Pill571 Progestin Only0.5 Combined0.1IUD Progesterone T2.01.581 Copper T380A0.80.678 LNg 200.10.181Depo-Provera®0.30.370Norplant® and Norplant-2®0.050.0588Female Sterilization0.50.5100Male Sterilization0.150.10100ORTHO TRI-CYCLEN® Lo has not been studied for and is not indicated for use in emergency contraception.

11-Digit NDC Billing Format:

54868473000

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: 578732 - norgestimate 0.18 MG / ethinyl estradiol 0.025 MG Oral Tablet

RxCUI: 578732 - ethinyl estradiol 0.025 MG / norgestimate 0.18 MG Oral Tablet

RxCUI: 578732 - ethinyl estradiol 25 MCG / norgestimate 180 MCG Oral Tablet

RxCUI: 748797 - inert 1 MG Oral Tablet

RxCUI: 748797 - inert ingredients 1 MG Oral Tablet

Labeler Name:

Physicians Total Care, Inc.

Sample Package:

Start Marketing Date:

01-23-2003

Listing Expiration Date:

12-31-2017

Exclude Flag:

Code Structure:

54868 - Physicians Total Care, Inc.
- 54868-4730 - Ortho Tri Cyclen Lo
  - 54868-4730-0 - 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 54868-4730-0?

The NDC Packaged Code 54868-4730-0 is assigned to a package of 1 kit in 1 blister pack of Ortho Tri Cyclen Lo, 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 54868-4730 included in the NDC Directory?

No, Ortho Tri Cyclen Lo with product code 54868-4730 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 January 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 54868-4730-0?

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 54868-4730-0?

The 11-digit format is 54868473000. 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	54868-4730-0	5-4-2	54868-4730-00

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