Tri-sprintec
NDC 54868-5028

View NDC Profile UNII Mappings and RxNorm Concepts.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54868-5028?
  5. Tri-sprintec Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Tri-sprintec is a ANDA-approved product labeled by Physicians Total Care, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 54868-5028 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
54868-5028
Proprietary Name:
Tri-sprintec
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
faafb8ce-6955-4de4-8b93-ccc662123b5e
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]
03-26-2004
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Product Characteristics

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

Code Structure Chart

Product Details

What is NDC 54868-5028?

The NDC code 54868-5028 is assigned by the FDA to the product Tri-sprintec. 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: 54868-5028-0. 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 Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.Tri-Sprintec Tablets are indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire contraception, have achieved menarche and are unresponsive to topical anti-acne medications.Oral contraceptives are highly effective. Table I 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, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.TABLE I: 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)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 T21.581 Copper T380A0.80.678 LNg 200.10.181Depo-Provera0.30.370Norplant and Norplant-20.050.0588Female Sterilization0.50.5100Male Sterilization0.150.10100Adapted from Hatcher et al., 1998 Ref. #1.In four clinical trials with norgestimate and ethinyl estradiol, the use-efficacy pregnancy rate ranged from 0.68 to 1.47 per 100 women-years. In total, 4,756 subjects completed 45,244 cycles and a total of 42 pregnancies were reported. This represents an overall use-efficacy rate of 1.21 per 100 women-years. One of these 4 studies was a randomized comparative clinical trial in which 4,633 subjects completed 22,312 cycles. Of the 2,312 patients on norgestimate and ethinyl estradiol, 8 pregnancies were reported. This represents an overall use-efficacy pregnancy rate of 0.94 per 100 women-years.In two double-blind, placebo-controlled, six month, multicenter clinical trials, norgestimate and ethinyl estradiol showed a statistically significant decrease in inflammatory lesion count and total lesion count (TABLE II). The adverse reaction profile of norgestimate and ethinyl estradiol from these two controlled clinical trials is consistent with what has been noted from previous studies involving norgestimate and ethinyl estradiol and are the known risks associated with oral contraceptives.TABLE II: Acne Vulgaris Indication Combined Results: Two Multicenter, Placebo-Controlled Trials Primary Efficacy Variables: Evaluable-for-Efficacy PopulationNorgestimate and Ethinyl EstradiolPlaceboN=163N=161Mean Age at Enrollment27.3 years28Inflammatory Lesions -56.636.6Mean Percent ReductionTotal Lesions -49.630.3Mean Percent Reduction

Which are the associated UNII Codes?

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

  • Tri-SprintecTriphasic Regimen Triphasic Regimen

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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Product & Regulatory Definitions
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".