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  4. NDC Product Code: 0113-8101 Opill

NDC 0113-8101 Opill

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

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0113-8101?
  5. Opill Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
0113-8101
Proprietary Name:
Opill
Non-Proprietary Name: [1]
Norgestrel
Substance Name: [2]
Norgestrel
NDC Directory Status:
Human Otc 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]
    L. Perrigo Company
    Labeler Code:
    0113
    Product Label ID:
    69dfa2ac-6a7e-4587-929c-9acabd97973b
    FDA Application Number: [6]
    NDA017031
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    03-04-2024
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330)
    Shape:
    ROUND (C48348)
    Size(s):
    5 MM
    Imprint(s):
    NG;75
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 0113-8101?

    The NDC code 0113-8101 is assigned by the FDA to the product Opill which is a human over the counter drug product labeled by L. Perrigo Company. The generic name of Opill is norgestrel. The product's dosage form is tablet and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 0113-8101-01 1 blister pack in 1 carton / 28 tablet in 1 blister pack, 0113-8101-03 3 blister pack in 1 carton / 28 tablet in 1 blister pack, 0113-8101-06 6 blister pack in 1 carton / 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 Opill?

    •take 1 tablet at the same time every day•this product will work best to prevent pregnancy when taken exactly as directed•you can start on any day of the month•use a condom (or another barrier method) every time you have sex during the first 2 days of use (48 hours) after you start your first pack of this product, because it takes 2 days for this product to start workingSee the enclosed leaflet for more information on how to switch from another contraceptive method.•never skip your daily tablet•to prevent pregnancy, take this product every day, even when you bleed or have spotting•when you finish this pack, start the next one the following day without a break•if you are more than 3 hours late taking your tablet or miss taking your tablet on 1 more days:•take 1 tablet immediately, as soon as you remember that you missed it•then go back to taking your daily tablet at your usual time•use a condom (or another barrier method) every time you have sex during the next 2 days (48 hours), because it takes 2 days for this product to start working again•if you vomit for any reason or have severe diarrhea within 4 hours of taking your daily tablet, use a condom (or another barrier method) every time you have sex for the next 2 days (48 hours), because the medicine may not have been fully absorbed•you should continue to see your healthcare provider(s) for routine healthcare visitsWhen to use a condom (or another barrier method)•every time you have sex for the next 2 days (48 hours):•after you start your first pack of this product•if you take a tablet more than 3 hours late or miss a tablet on 1 or more days•if you vomit or have a severe diarrhea within 4 hours of taking a tablet

    What are Opill 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.
    • NORGESTREL .075 mg/1 - A synthetic progestational agent with actions similar to those of PROGESTERONE. This racemic or (+-)-form has about half the potency of the levo form (LEVONORGESTREL). Norgestrel is used as a contraceptive, ovulation inhibitor, and for the control of menstrual disorders and endometriosis.

    Which are Opill UNII Codes?

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

    Which are Opill 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 Opill?

    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:

    * 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".