NDC 68180-827 Fyavolv

Norethindrone Acetate And Ethinyl Estradiol Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
68180-827
Proprietary Name:
Fyavolv
Non-Proprietary Name: [1]
Norethindrone Acetate And Ethinyl Estradiol
Substance Name: [2]
Ethinyl Estradiol; Norethindrone Acetate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Lupin Pharmaceuticals, Inc.
    Labeler Code:
    68180
    FDA Application Number: [6]
    ANDA204213
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    03-15-2016
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - WHITE TO OFF-WHITE)
    Shape:
    ROUND (C48348)
    Size(s):
    6 MM
    Imprint(s):
    LU;F51
    Score:
    1

    Product Packages

    NDC Code 68180-827-09

    Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $1.41508 per EA

    NDC Code 68180-827-73

    Package Description: 3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK

    Price per Unit: $1.41508 per EA

    Product Details

    What is NDC 68180-827?

    The NDC code 68180-827 is assigned by the FDA to the product Fyavolv which is a human prescription drug product labeled by Lupin Pharmaceuticals, Inc.. The generic name of Fyavolv is norethindrone acetate and ethinyl estradiol. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 68180-827-09 90 tablet, film coated in 1 bottle , 68180-827-73 3 pouch in 1 carton / 1 blister pack in 1 pouch / 28 tablet, film coated 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 Fyavolv?

    This medication contains 2 female hormones: an estrogen (such as conjugated estrogen, estradiol) and a progestin (such as medroxyprogesterone, norethindrone, norgestimate). It is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). These symptoms are caused by the body making less estrogen. The progestin in this medication helps to reduce the risk of cancer of the uterus which can be caused by using estrogen. Women who have had their uterus removed do not need the progestin and therefore should not use this combination medication. If you are using this medication to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected. This medication may also be used by women after menopause to prevent bone loss (osteoporosis). However, there are other medications (such as raloxifene, bisphosphonates including alendronate) that are also effective in preventing bone loss and may be safer. These medications should be considered for use before estrogen/progestin treatment.

    What are Fyavolv 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 .0025 mg/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.
    • NORETHINDRONE ACETATE .5 mg/1 - Acetate ester of norethindrone that is used as a long-term contraceptive (CONTRACEPTIVE AGENTS).

    Which are Fyavolv UNII Codes?

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

    Which are Fyavolv 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 Fyavolv?

    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: 1090992 - norethindrone acetate 1 MG / ethinyl estradiol 5 MCG Oral Tablet
    • RxCUI: 1090992 - ethinyl estradiol 0.005 MG / norethindrone acetate 1 MG Oral Tablet
    • RxCUI: 1090992 - ethinyl estradiol 5 MCG / norethindrone acetate 1 MG Oral Tablet
    • RxCUI: 1251323 - norethindrone acetate 0.5 MG / ethinyl estradiol 2.5 MCG Oral Tablet
    • RxCUI: 1251323 - ethinyl estradiol 0.0025 MG / norethindrone acetate 0.5 MG Oral Tablet

    Which are the Pharmacologic Classes for Fyavolv?

    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".