NDC Package 54868-4093-0 Ortho Tri Cyclen
View Billable Units, 11-Digit Format, RxNorm
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:
54868-4093-0
Package Description:
1 KIT in 1 DIALPACK
Product Code:
Proprietary Name:
Ortho Tri Cyclen
Usage Information:
ORTHO-CYCLEN® and ORTHO TRI-CYCLEN® Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.ORTHO TRI-CYCLEN is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. ORTHO TRI-CYCLEN should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. Oral contraceptives are highly effective for pregnancy prevention. Table II 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 II: 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 YearAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.MethodTypical 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.Perfect UseAmong 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.(1)(2)(3)(4)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 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.ChanceThe 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.8585SpermicidesFoams, creams, gels, vaginal suppositories, and vaginal film.26640Periodic abstinence2563 Calendar9 Ovulation Method3 Sympto-ThermalCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.2 Post-Ovulation1CapWith spermicidal cream or jelly. Parous Women402642 Nulliparous Women20956Sponge Parous Women402042 Nulliparous Women20956Diaphragm20656Withdrawal194CondomWithout spermicides. Female (Reality)21556 Male14361Pill571 Progestin Only0.5 Combined0.1IUD Progesterone T2.01.581 Copper T380A0.80.678 LNg 200.10.181Depo-Provera0.30.370Norplant and Norplant-20.050.0588Female Sterilization0.50.5100Male Sterilization0.150.10100ORTHO-CYCLEN and ORTHO TRI-CYCLEN have not been studied for and are not indicated for use in emergency contraception.In clinical trials with ORTHO-CYCLEN, 1,651 subjects completed 24,272 cycles and the overall use-efficacy (typical user efficacy) pregnancy rate was approximately 1 pregnancy per 100 women-years. This rate includes patients who did not take the drug correctly.In four clinical trials with ORTHO TRI-CYCLEN, a total of 4,756 subjects completed 45,244 cycles, and the use-efficacy pregnancy rate was approximately 1 pregnancy per 100 women-years. ORTHO TRI-CYCLEN was evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28 day) cycle studies. 221 patients received ORTHO TRI-CYCLEN and 234 patients received placebo. Mean age at enrollment for both groups was 28 years. At the end of 6 months, the mean total lesion count changes from 55 to 31 (42% reduction) in patients treated with ORTHO TRI-CYCLEN and from 54 to 38 (27% reduction) in patients similarly treated with placebo. Table III summarizes the changes in lesion count for each type of lesion in the ITT population. Based on the investigator's global assessment conducted at the final visit, patients treated with ORTHO TRI-CYCLEN showed a statistically significant improvement in total lesions compared to those treated with placebo.Table III: Acne Vulgaris Indication. Combined Results: Two Multicenter, Placebo-Controlled Trials. Observed Means at Six Months (LOCF)LOCF: Last Observation Carried Forward and at Baseline. Intent-to-Treat Population.ORTHO TRI-CYCLEN (N=221)Placebo (N=234)Difference in Counts between ORTHO TRI-CYCLEN and Placebo at 6 Months# of LesionsCounts% ReductionCounts% ReductionINFLAMMATORY LESIONS Baseline Mean1919 Sixth Month Mean1048%1330%3 (95 % CI: -1.2, 5.1)NON-INFLAMMATORY LESIONS Baseline Mean3635 Sixth Month Mean2234%2521%3 (95% CI: -0.2, 7.8)TOTAL LESIONS Baseline Mean5554 Sixth Month Mean3142%3827%7 (95% CI: 2.0, 11.9)
11-Digit NDC Billing Format:
54868409300
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:
Labeler Name:
Physicians Total Care, Inc.
Sample Package:
No
Start Marketing Date:
05-13-2005
Listing Expiration Date:
12-31-2017
Exclude Flag:
I
Code Structure:
- 54868 - Physicians Total Care, Inc.
- 54868-4093 - Ortho Tri Cyclen
- 54868-4093-0 - 1 KIT in 1 DIALPACK
- 54868-4093 - Ortho Tri Cyclen
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.
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Frequently Asked Questions
What is NDC 54868-4093-0?
The NDC Packaged Code 54868-4093-0 is assigned to a package of 1 kit in 1 dialpack of Ortho Tri Cyclen, 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 54868-4093 included in the NDC Directory?
No, Ortho Tri Cyclen with product code 54868-4093 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 May 13, 2005 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 54868-4093-0?
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 54868-4093-0?
The 11-digit format is 54868409300. 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 | 54868-4093-0 | 5-4-2 | 54868-4093-00 |