Tri-sprintec Kit
NDC 63187-458

Kit
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 63187-458?
  5. Tri-sprintec Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

Tri-sprintec (norgestimate and ethinyl estradiol) is a ANDA-approved product labeled by Proficient Rx Lp. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a kit. This product entry covers the primary NDC 63187-458 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
63187-458
Proprietary Name:
Tri-sprintec
Non-Proprietary Name: [1]
Norgestimate And Ethinyl Estradiol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

Labeler Name: [5]
Proficient Rx Lp
Labeler Code:
63187
Product Label ID:
c1fc22e5-e02d-4dda-a9ac-c592e922c467
FDA Application Number: [6]
ANDA075808
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
12-29-2003
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Product Characteristics

Color(s):
Tri-Sprintec: GRAY (C48324)
Tri-Sprintec: BLUE (C48333 - LIGHT BLUE)
Tri-Sprintec: BLUE (C48333)
Inert: WHITE (C48325)
Shape:
Tri-Sprintec: ROUND (C48348)
Inert: ROUND (C48348)
Size(s):
Tri-Sprintec: 6 MM
Inert: 6 MM
Imprint(s):
Tri-Sprintec: B;985
Tri-Sprintec: B;986
Tri-Sprintec: B;987
Inert: B;143
Score:
Tri-Sprintec: 1
Inert: 1

Code Structure Chart

Product Details

What is NDC 63187-458?

The NDC code 63187-458 is assigned by the FDA to the product Tri-sprintec. It is commonly known by its generic name, norgestimate and ethinyl estradiol. This pharmaceutical product is labeled by Proficient Rx Lp and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 63187-458-28. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Tri-Sprintec® (norgestimate and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) 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. Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) 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 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 YearAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.MethodTypical UseAmong 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)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 T21.581 Copper T380A0.80.678 LNg 200.10.181Depo-Provera®0.30.370Norplant® and Norplant-2®0.050.0588Female Sterilization0.50.5100Male Sterilization0.150.10100Hatcher 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 ofcontraception. 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.Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) has not been studied for and is not indicated for use in emergency contraception.In four clinical trials with Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP), a total of 4,756 subjects completed 45,244 cycles, and the use-efficacy pregnancy rate was approximately 1 pregnancy per 100 women-years.Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) 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 Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) 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 Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) and from 54 to 38 (27% reduction) in patients similarly treated with placebo. Table 3 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 Tri-Sprintec (norgestimate and ethinyl estradiol tablets USP) showed a statistically significant improvement in total lesions compared to those treated with placebo.Table 3: 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.Tri-Sprintec(N = 221)Placebo(N = 234)Difference in Counts Between Tri-Sprintec and Placebo at 6 Months# of LesionsCounts% ReductionCounts% ReductionINFLAMMATORY LESIONS Baseline Mean1919 Sixth Month Mean1048%1330%3 (95% CI: -1.2, 5.1)NON-INFLAMMATORYLESIONS 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, 11.9)

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

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

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Patient Education

Estrogen and Progestin (Oral Contraceptives)


Oral contraceptives (birth-control pills) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries). They also change the lining of the uterus (womb) to prevent pregnancy from developing and change the mucus at the cervix (opening of the uterus) to prevent sperm (male reproductive cells) from entering. Oral contraceptives are a very effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases. Some brands of oral contraceptives are also used to treat acne in certain patients. Oral contraceptives treat acne by decreasing the amounts of certain natural substances that can cause acne. Some oral contraceptives (Beyaz, Yaz) are also used to relieve the symptoms of premenstrual dysphoric disorder (physical and emotional symptoms that occur before the menstrual period each month) in women who have chosen to use an oral contraceptive to prevent pregnancy.
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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".