Trinessa
NDC 54868-5826

The NDC code 54868-5826 is assigned by the FDA to the product Trinessa. This pharmaceutical product is labeled by Physicians Total Care, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 54868-5826-0. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

TriNessa® is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.TriNessa® 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. TriNessa® 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 Year MethodTypical Use Perfect Use (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 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.Chance 8585Spermicides 26640Periodic abstinence2563  Calendar9  Ovulation Method3  Sympto-Thermal 2  Post-Ovulation1CapWith spermicidal cream or jelly.  Parous Women402642  Nulliparous Women20956Sponge  Parous Women402042  Nulliparous Women20956Diaphragm20656Withdrawal194Condom   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 Sterilization0.150.10100TriNessa® has not been studied for and is not indicated for use in emergency contraception.In four clinical trials with TriNessa®, a total of 4,756 subjects completed 45,244 cycles, and the use-efficacy pregnancy rate was approximately 1 pregnancy per 100 women-years.TriNessa® 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 TriNessa® 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 TriNessa® 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 TriNessa® 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.TriNessa® (N=221)Placebo (N=234)Difference in Counts between TriNessa® 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)

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

• RxCUI: 240128 - norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral Tablet
• RxCUI: 240128 - ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet
• RxCUI: 240128 - ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral Tablet
• RxCUI: 406396 - norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral Tablet
• RxCUI: 406396 - ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet