NDC 68382-257 Oxybutynin

Tablet, Film Coated, Extended Release Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
68382-257
Proprietary Name:
Oxybutynin
Non-Proprietary Name: [1]
Oxybutynin
Substance Name: [2]
Oxybutynin Chloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Zydus Pharmaceuticals Usa Inc.
    Labeler Code:
    68382
    FDA Application Number: [6]
    ANDA202332
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    08-10-2017
    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):
    7 MM
    Imprint(s):
    255
    256
    257
    Score:
    1

    Product Packages

    NDC Code 68382-257-01

    Package Description: 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

    Price per Unit: $0.12984 per EA

    NDC Code 68382-257-05

    Package Description: 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

    NDC Code 68382-257-06

    Package Description: 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

    NDC Code 68382-257-14

    Package Description: 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

    NDC Code 68382-257-16

    Package Description: 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

    NDC Code 68382-257-77

    Package Description: 10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-257-30)

    Product Details

    What is NDC 68382-257?

    The NDC code 68382-257 is assigned by the FDA to the product Oxybutynin which is a human prescription drug product labeled by Zydus Pharmaceuticals Usa Inc.. The product's dosage form is tablet, film coated, extended release and is administered via oral form. The product is distributed in 6 packages with assigned NDC codes 68382-257-01 100 tablet, film coated, extended release in 1 bottle , 68382-257-05 500 tablet, film coated, extended release in 1 bottle , 68382-257-06 30 tablet, film coated, extended release in 1 bottle , 68382-257-14 60 tablet, film coated, extended release in 1 bottle , 68382-257-16 90 tablet, film coated, extended release in 1 bottle , 68382-257-77 10 blister pack in 1 carton / 10 tablet, film coated, extended release in 1 blister pack (68382-257-30). 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 Oxybutynin?

    Oxybutynin is used to treat an overactive bladder. By relaxing the muscles in the bladder, oxybutynin improves symptoms such as the inability to control urination (incontinence), feeling that one has to urinate (urgency), and having to go to the bathroom often (frequency). This medication belongs to the class of drugs known as antispasmodics. This medication is not recommended for use in children younger than 5 years of age. Consult your doctor for more information. Unless otherwise directed by your doctor, the over-the-counter product should only be used by adult women who have symptoms of overactive bladder for at least 2 months. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

    What are Oxybutynin 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 Oxybutynin UNII Codes?

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

    Which are Oxybutynin 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 Oxybutynin?

    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: 863619 - oxyBUTYnin chloride 10 MG 24HR Extended Release Oral Tablet
    • RxCUI: 863619 - 24 HR oxybutynin chloride 10 MG Extended Release Oral Tablet
    • RxCUI: 863619 - oxybutynin chloride 10 MG 24 HR Extended Release Oral Tablet
    • RxCUI: 863628 - oxyBUTYnin chloride 15 MG 24HR Extended Release Oral Tablet
    • RxCUI: 863628 - 24 HR oxybutynin chloride 15 MG Extended Release Oral Tablet

    Which are the Pharmacologic Classes for Oxybutynin?

    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

    Oxybutynin


    Oxybutynin is used to treat overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination) in certain adults and children. Oxybutynin is also used as an extended-release tablet to control bladder muscles in adults and children 6 years of age and older with spina bifida (a disability that occurs when the spinal cord does not close properly before birth), or other nervous system conditions that affect the bladder muscles. Oxybutynin is in a class of medications called anticholinergics/antimuscarinics. It works by relaxing the bladder 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".