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  4. NDC Product Code: 54868-5286 Nortrel 7/7/7 (28 Day Regimen)

NDC 54868-5286 Nortrel 7/7/7 (28 Day Regimen)

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54868-5286?
  5. Nortrel 7/7/7 (28 Day Regimen) 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.

Get all the details for National Drug Code (NDC) 54868-5286 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
54868-5286
Proprietary Name:
Nortrel 7/7/7 (28 Day Regimen)
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
70441908-2e6c-4fdc-9544-e93a5a7223d4
FDA Application Number: [6]
ANDA075478
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
08-19-2008
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330)
BLUE (C48333)
ORANGE (C48331 - PEACH)
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
B;951
B;942
B;943
Score:
1

Code Structure Chart

Product Details

What is NDC 54868-5286?

The NDC code 54868-5286 is assigned by the FDA to the product Nortrel 7/7/7 (28 Day Regimen) which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 54868-5286-0 1 blister pack in 1 pouch / 1 kit in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Nortrel 7/7/7 (28 Day Regimen)?

Nortrel™ 7/7/7 (norethindrone and ethinyl estradiol tablets, USP 0.5/0.035 mg, 0.75/0.035 mg, and 1/0.035 mg) (21 Day Regimen and 28 Day Regimen) are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.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 STATESAdapted from Hatcher et al., 1998 Ref. #1.% 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 abstinence 2563Calendar 9Ovulation Method 3Sympto-Thermal 2Post-Ovulation1Withdrawal 194Cap With spermicidal cream or jelly.Parous Women 402642Nulliparous Women 20956SpongeParous Women 402042Nulliparous Women 20956Diaphragm 20656Condom Female (Reality) 21556Male 14361Pill 571Progestin Only 0.5Combined 0.1IUDProgesterone T 2.01.581Copper T380A 0.80.678LNg 20 0.10.181Depo-Provera 0.30.370Norplant and Norplant-2 0.050.0588Female Sterilization 0.50.5100Male Sterilization 0.150.10100

Which are Nortrel 7/7/7 (28 Day Regimen) UNII Codes?

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

Which are Nortrel 7/7/7 (28 Day Regimen) Inactive Ingredients 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 Nortrel 7/7/7 (28 Day Regimen)?

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: 310463 - norethindrone 0.5 MG / ethinyl estradiol 0.035 MG Oral Tablet
  • RxCUI: 310463 - ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet
  • RxCUI: 310463 - ethinyl estradiol 35 MCG / norethindrone 0.5 MG Oral Tablet
  • RxCUI: 312033 - norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral Tablet
  • RxCUI: 312033 - ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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".