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  4. NDC Product Code: 68462-637 Levonorgestrel And Ethinyl Estradiol

NDC 68462-637 Levonorgestrel And Ethinyl Estradiol

Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 68462-637?
  5. Levonorgestrel And Ethinyl Estradiol Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
68462-637
Proprietary Name:
Levonorgestrel And Ethinyl Estradiol
Non-Proprietary Name: [1]
Levonorgestrel And Ethinyl Estradiol
Substance Name: [2]
Ethinyl Estradiol; Levonorgestrel
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Glenmark Pharmaceuticals Inc., Usa
    Labeler Code:
    68462
    Product Label ID:
    44fbc5ae-5682-471f-a12a-955e8b4d233a
    FDA Application Number: [6]
    ANDA202791
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    04-09-2015
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    BROWN (C48332 - BROWNISH PEACH TO LIGHT BROWN)
    Shape:
    ROUND (C48348)
    Size(s):
    6 MM
    Imprint(s):
    E8
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 68462-637?

    The NDC code 68462-637 is assigned by the FDA to the product Levonorgestrel And Ethinyl Estradiol which is a human prescription drug product labeled by Glenmark Pharmaceuticals Inc., Usa. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 68462-637-29 3 pouch in 1 carton / 1 blister pack in 1 pouch / 28 tablet 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 Levonorgestrel And Ethinyl Estradiol?

    Levonorgestrel 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.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 implants, depend 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 WomenContinuing Use at One Year3Method (1)Typical Use1 (2)Perfect Use2 (3)(4)Chance48585Spermicides526640Periodic abstinence2563   Calendar 9   Ovulation Method3   Sympto-Thermal62   Post-Ovulation1Cap7   Parous Women402642   Nulliparous Women20956Sponge    Parous Women402042   Nulliparous Women20956Diaphragm720656Withdrawal194Condom8   Female (RealityTM)21556   Male14361Pill571   Progestin only0.5   Combined0.1IUD    Progesterone T2.01.581   Copper T380A0.80.678   LNg 200.10.181Depo-Provera®0.30.370LevonorgestrelImplants (Norplant®)0.050.0588Female Sterilization0.50.5100Male Sterilization0.150.10100Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel 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 accidental 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 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.3.Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.4.The 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.5.Foams, creams, gels, vaginal suppositories, and vaginal film.6.Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.7.With spermicidal cream or jelly.8.Without 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 FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 0.05 mg of ethinyl estradiol and 0.50 mg of norgestrel 1 dose is 2 tablets; for tablets containing 0.02 mg of ethinyl estradiol and 0.1 mg of levonorgestrel 1 dose is 5 tablets; for tablets containing 0.03 mg of ethinyl estradiol and 0.15 mg of levonorgestrel 1 dose is 4 tablets.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 6 months of age.

    What are Levonorgestrel And Ethinyl Estradiol Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • ETHINYL ESTRADIOL 20 ug/1 - A semisynthetic alkylated ESTRADIOL with a 17-alpha-ethinyl substitution. It has high estrogenic potency when administered orally, and is often used as the estrogenic component in ORAL CONTRACEPTIVES.
    • LEVONORGESTREL 90 ug/1 - A synthetic progestational hormone with actions similar to those of PROGESTERONE and about twice as potent as its racemic or (+-)-isomer (NORGESTREL). It is used for contraception, control of menstrual disorders, and treatment of endometriosis.

    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:

    What is the NDC to RxNorm Crosswalk for Levonorgestrel And Ethinyl Estradiol?

    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: 722152 - ethinyl estradiol 20 MCG / levonorgestrel 90 MCG Oral Tablet
    • RxCUI: 722152 - ethinyl estradiol 0.02 MG / levonorgestrel 0.09 MG Oral Tablet
    • RxCUI: 751553 - {28 (ethinyl estradiol 0.02 MG / levonorgestrel 0.09 MG Oral Tablet) } Pack
    • RxCUI: 751553 - Eth estra-Levonorgest 0.02-0.09 MG (28) Oral Tablet 28 Day Pack

    Which are the Pharmacologic Classes for Levonorgestrel And Ethinyl Estradiol?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    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.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".