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  4. NDC Product Code: 0065-0396 Cyclogyl

NDC 0065-0396 Cyclogyl

Cyclopentolate Hydrochloride Solution/ Drops Ophthalmic - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0065-0396?
  4. Cyclogyl Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

NDC Product Code:
0065-0396
Proprietary Name:
Cyclogyl
Non-Proprietary Name: [1]
Cyclopentolate Hydrochloride
Substance Name: [2]
Cyclopentolate Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route(s): [4]
  • Ophthalmic - Administration to the external eye.
    • Labeler Name: [5]
    Alcon Laboratories, Inc.
    Labeler Code:
    0065
    Product Label ID:
    1d008c76-7210-4ace-90fa-7cd22762e12e
    FDA Application Number: [6]
    ANDA084110
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    10-15-1975
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0065-0396-02

    Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 2 mL in 1 BOTTLE, PLASTIC

    NDC Code 0065-0396-05

    Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC

    Price per Unit: $7.91200 per ML

    Product Details

    What is NDC 0065-0396?

    The NDC code 0065-0396 is assigned by the FDA to the product Cyclogyl which is a human prescription drug product labeled by Alcon Laboratories, Inc.. The generic name of Cyclogyl is cyclopentolate hydrochloride. The product's dosage form is solution/ drops and is administered via ophthalmic form. The product is distributed in 2 packages with assigned NDC codes 0065-0396-02 1 bottle, plastic in 1 carton / 2 ml in 1 bottle, plastic, 0065-0396-05 1 bottle, plastic in 1 carton / 5 ml in 1 bottle, plastic. 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 Cyclogyl?

    This medication is used before eye examinations (e.g., refraction exams). It belongs to a class of drugs known as anticholinergics. Cyclopentolate works by temporarily widening (dilating) the pupil of the eye and relaxing the muscles of the eye.

    What are Cyclogyl 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.

    Which are Cyclogyl UNII Codes?

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

    Which are Cyclogyl 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 Cyclogyl?

    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.

    Patient Education

    Cyclopentolate Ophthalmic


    Cyclopentolate ophthalmic is used to cause mydriasis (pupil dilation) and cycloplegia (paralysis of the ciliary muscle of the eye) before an eye examination. Cyclopentolate is in a class of medications called mydriatics. Cyclopentolate works by blocking certain receptors found in the eye to temporarily relax or provide short-term paralysis of the eye muscles.
    [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".