Jolessa
NDC Package 54868-6044-0

11-digit billing NDC: 54868604400 · Billing unit: EA · 1 EA per package
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.

Jolessa is ™ tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.In a 1-year controlled clinical trial, 4 pregnancies occurred in women 18-35 years of age during 809 completed 91-day cycles of Jolessa™ during which no backup contraception was utilized. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-6044 and is authorized under FDA application NDA021544.

Identification & Billing

NDC Package Code
54868-6044-0
Package Description
1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
Product Code
54868-6044
11-Digit Billing Format
54868604400
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: 238019 - levonorgestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet
  • RxCUI: 238019 - ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet
  • RxCUI: 748797 - inert 1 MG Oral Tablet
  • RxCUI: 748797 - inert ingredients 1 MG Oral Tablet
  • RxCUI: 751901 - {84 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack

Clinical Specifications

Proprietary Name
Jolessa
Dosage Form
-
Usage Information
Jolessa™ tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.In a 1-year controlled clinical trial, 4 pregnancies occurred in women 18-35 years of age during 809 completed 91-day cycles of Jolessa™ during which no backup contraception was utilized. This represents an overall use-efficacy (typical user efficacy) pregnancy rate of 1.98 per 100 women-years of use.Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and Norplant® Implant 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*Method(1)Typical Use†(2)Perfect Use‡(3)(4)Chance§ 8585Spermicides¶ 26640Periodic abstinence2563   Calendar9   Ovulation method3   Sympto-thermal # 2   Post-ovulation1Withdrawal194Cap Þ    Parous women402642   Nulliparous women20956Sponge   Parous women402042   Nulliparous women20956Diaphragm Þ 20656Condom ß   Female (Reality)21556   Male14361Pill571   Progestin only0.5   Combined0.1IUD:   Progesterone T2.01.581   Copper T 380A0.80.678   LNg 200.10.181Depo Provera0.30.370Norplant and Norplant-20.050.0588Female sterilization0.50.5100Male sterilization0.150.10100Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. àLactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. èSource: 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.*Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.†Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an unintended pregnancy during the first year if they do not stop use for any other reason.‡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 unintended pregnancy during the first year if they do not stop use for any other reason.§The percentages of women 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 percentage who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.¶Foams, creams, gels, vaginal suppositories and vaginal film.#Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.ÞWith spermicidal cream or jelly.ßWithout spermicides.àThe 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).èHowever, 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.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA021544
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-24-2009
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 54868-6044-0 identifies a specific commercial package of 1 blister pack in 1 pouch / 1 kit in 1 blister pack of Jolessa, 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 June 24, 2009. 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: 54868604400. 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)
54868-6044-0
11-Digit CMS (5-4-2)
54868-6044-00

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