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NDC 64108-212 Minidrops

Lubricant Eye Drops Liquid Ophthalmic - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 64108-212?
  4. Minidrops Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
64108-212
Proprietary Name:
Minidrops
Non-Proprietary Name: [1]
Lubricant Eye Drops
Substance Name: [2]
Polyvinyl Alcohol; Povidone, Unspecified
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s): [4]
  • Ophthalmic - Administration to the external eye.
    • Labeler Name: [5]
    Optics Laboratory, Inc
    Labeler Code:
    64108
    Product Label ID:
    c13c5f91-50df-471c-a7c9-1747a2ac1250
    FDA Application Number: [6]
    M018
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    04-01-1991
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 64108-212?

    The NDC code 64108-212 is assigned by the FDA to the product Minidrops which is a human over the counter drug product labeled by Optics Laboratory, Inc. The generic name of Minidrops is lubricant eye drops. The product's dosage form is liquid and is administered via ophthalmic form. The product is distributed in 3 packages with assigned NDC codes 64108-212-12 30 vial, single-use in 1 box / .5 ml in 1 vial, single-use (64108-212-10), 64108-212-13 5 vial, single-use in 1 box / .5 ml in 1 vial, single-use (64108-212-10), 64108-212-65 65 vial, single-use in 1 box / .5 ml in 1 vial, single-use (64108-212-10). 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 Minidrops?

    INDICATIONS: FOR THE TEMPORARY RELIEF OF BURNING AND IRRITATION DUE TO DRYNESS OF THE EYE.  FOR USE AS A LUBRICANT TO PREVENT FURTHER IRRITATION OR TO RELIEVE DRYNESS OF THE EYE.

    What are Minidrops 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.
    • POLYVINYL ALCOHOL 14 mg/mL - A polymer prepared from polyvinyl acetates by replacement of the acetate groups with hydroxyl groups. It is used as a pharmaceutic aid and ophthalmic lubricant as well as in the manufacture of surface coatings artificial sponges, cosmetics, and other products.
    • POVIDONE, UNSPECIFIED 6 mg/mL - A polyvinyl polymer of variable molecular weight; used as suspending and dispersing agent and vehicle for pharmaceuticals; also used as blood volume expander.

    Which are Minidrops UNII Codes?

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

    Which are Minidrops 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 Minidrops?

    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: 1046287 - MiniDrops 1.4 % / 0.6 % Ophthalmic Solution
    • RxCUI: 1046287 - polyvinyl alcohol 0.014 ML/ML / povidone 6 MG/ML Ophthalmic Solution [MiniDrops]
    • RxCUI: 1046287 - MiniDrops (polyvinyl alcohol 1.4 % / povidone 0.6 % ) Ophthalmic Solution
    • RxCUI: 359969 - polyvinyl alcohol 1.4 % / povidone 0.6 % Ophthalmic Solution
    • RxCUI: 359969 - polyvinyl alcohol 0.014 ML/ML / povidone 6 MG/ML Ophthalmic Solution

    * 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".