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  4. NDC Product Code: 75834-129 Norethindrone Acetate And Ethinyl Estradiol

NDC 75834-129 Norethindrone Acetate 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 75834-129?
  5. Norethindrone Acetate 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:
75834-129
Proprietary Name:
Norethindrone Acetate And Ethinyl Estradiol
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 - 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]
    Nivagen Pharmaceuticals, Inc.
    Labeler Code:
    75834
    Product Label ID:
    2c2a37e1-adaf-4947-abb1-736bfa58bf98
    FDA Application Number: [6]
    ANDA203435
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    11-25-2016
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    YELLOW (C48330 - LIGHT)
    Shape:
    ROUND (C48348)
    Size(s):
    5 MM
    Imprint(s):
    N2
    N1
    Score:
    1

    Product Packages

    NDC Code 75834-129-29

    Package Description: 3 BLISTER PACK in 1 CARTON / 28 TABLET in 1 BLISTER PACK (75834-129-84)

    Price per Unit: $1.27006 per EA

    NDC Code 75834-129-90

    Package Description: 90 TABLET in 1 BOTTLE

    Product Details

    What is NDC 75834-129?

    The NDC code 75834-129 is assigned by the FDA to the product Norethindrone Acetate And Ethinyl Estradiol which is a human prescription drug product labeled by Nivagen Pharmaceuticals, Inc.. The product's dosage form is tablet and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 75834-129-29 3 blister pack in 1 carton / 28 tablet in 1 blister pack (75834-129-84), 75834-129-90 90 tablet in 1 bottle . 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 Norethindrone Acetate And Ethinyl Estradiol?

    Norethindrone acetate and ethinyl estradiol tablets are contraindicated in women with any of the following conditions:Undiagnosed abnormal genital bleedingKnown, suspected, or history of breast cancerKnown or suspected estrogen-dependent neoplasiaActive DVT, PE or a history of these conditionsActive arterial thromboembolic disease (for example, stroke and MI), or a history of these conditionsKnown anaphylactic reaction or angioedema to Norethindrone acetate and Ethinyl estradiol tablets.Known liver impairment or diseaseKnown protein C, protein S, or antithrombin deficiency, or other known thrombophilic disordersKnown or suspected pregnancy

    What are Norethindrone Acetate 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 .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 Norethindrone Acetate And Ethinyl Estradiol UNII Codes?

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

    Which are Norethindrone Acetate 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 Norethindrone Acetate 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: 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 Norethindrone Acetate 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".