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  4. NDC Product Code: 57297-843 Levonorgestrel And Ethinyl Estradiol

NDC 57297-843 Levonorgestrel And Ethinyl Estradiol

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 57297-843?
  5. Levonorgestrel And Ethinyl Estradiol Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 57297-843 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:
57297-843
Proprietary Name:
Levonorgestrel And Ethinyl Estradiol
Product Type: [3]
Labeler Name: [5]
Lupin Limited
Labeler Code:
57297
Product Label ID:
068199a9-ef22-4061-bb76-1ee58f726018
FDA Application Number: [6]
ANDA091440
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
10-24-2012
End Marketing Date: [10]
10-25-2012
Listing Expiration Date: [11]
10-25-2012
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328 - PINK)
WHITE (C48325 - WHITE TO OFF WHITE)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
LU;U21
LU;U22
Score:
1

Code Structure Chart

Product Details

What is NDC 57297-843?

The NDC code 57297-843 is assigned by the FDA to the product Levonorgestrel And Ethinyl Estradiol which is product labeled by Lupin Limited. The product's dosage form is . The product is distributed in a single package with assigned NDC code 57297-843-13 3 blister pack in 1 carton / 1 kit in 1 blister pack (57297-843-11). 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 Levonorgestrel And Ethinyl Estradiol?

Levonorgestrel and Ethinyl Estradiol Tablets USP 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 to 35 years of age during 809 completed 91-day cycles of levonorgestrel and ethinyl estradiol tablets 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 anUnintended Pregnancywithin the First Year of Use% of WomenContinuing Useat One Year 3Source: 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, 1998.1 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.2 Among couples who initiate use of a method (not necessarily for the first time) and who use it erfectly (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.3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.4 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 ear. This estimate was lowered slightly (to 85%) to represent the percentage who would ecome pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.5 Foams, creams, gels, vaginal suppositories and vaginal film.6Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basalbody temperature in the post-ovulatory phases.7With spermicidal cream or jelly.8Without spermicides.9 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 rands 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).10 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.Method (1)Typical Use1 (2)Perfect Use2 (3)(4)Chance 48585Spermicides 526640Periodic abstinence2563      Calendar9      Ovulation method3      Sympto-thermal 62      Post-ovulation1Withdrawal194Cap 7      Parous women402642      Nulliparous women20956Sponge      Parous women402042      Nulliparous women20956Diaphragm 720656Condom 8      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%. 9Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. 10

Which are Levonorgestrel And Ethinyl Estradiol UNII Codes?

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

Which are Levonorgestrel And Ethinyl Estradiol 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:

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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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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".