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  4. NDC Product Code: 60505-0033 Pentoxifylline

NDC 60505-0033 Pentoxifylline

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

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 60505-0033?
  5. Pentoxifylline 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:
60505-0033
Proprietary Name:
Pentoxifylline
Non-Proprietary Name: [1]
Pentoxifylline
Substance Name: [2]
Pentoxifylline
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Apotex Corp.
    Labeler Code:
    60505
    Product Label ID:
    40ae2d9a-0d95-640d-0640-f76e7e1a13cb
    FDA Application Number: [6]
    ANDA075191
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    06-10-1999
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Shape:
    OVAL (C48345)
    Size(s):
    16 MM
    Imprint(s):
    APO;033
    Score:
    1

    Product Packages

    NDC Code 60505-0033-6

    Package Description: 100 TABLET, EXTENDED RELEASE in 1 BOTTLE

    Price per Unit: $0.23333 per EA

    NDC Code 60505-0033-7

    Package Description: 500 TABLET, EXTENDED RELEASE in 1 BOTTLE

    Price per Unit: $0.23333 per EA

    Product Details

    What is NDC 60505-0033?

    The NDC code 60505-0033 is assigned by the FDA to the product Pentoxifylline which is a human prescription drug product labeled by Apotex Corp.. The product's dosage form is tablet, extended release and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 60505-0033-6 100 tablet, extended release in 1 bottle , 60505-0033-7 500 tablet, extended release 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 Pentoxifylline?

    This medication is used to improve the symptoms of a certain blood flow problem in the legs/arms (intermittent claudication due to occlusive artery disease). Pentoxifylline can decrease the muscle aching/pain/cramps during exercise, including walking, that occur with intermittent claudication. Pentoxifylline belongs to a class of drugs known as hemorrheologic agents. It works by helping blood flow more easily through narrowed arteries. This increases the amount of oxygen that can be delivered by the blood when the muscles need more (such as during exercise) thereby increasing walking distance and duration.

    What are Pentoxifylline 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.
    • PENTOXIFYLLINE 400 mg/1 - A METHYLXANTHINE derivative that inhibits phosphodiesterase and affects blood rheology. It improves blood flow by increasing erythrocyte and leukocyte flexibility. It also inhibits platelet aggregation. Pentoxifylline modulates immunologic activity by stimulating cytokine production.

    Which are Pentoxifylline UNII Codes?

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

    Which are Pentoxifylline 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 Pentoxifylline?

    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 code indicates a single concept unique identifier (RXCUI) is associated with this product:
    • RxCUI: 312301 - pentoxifylline 400 MG Extended Release Oral Tablet

    Which are the Pharmacologic Classes for Pentoxifylline?

    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

    Pentoxifylline


    Pentoxifylline is used to improve blood flow in patients with circulation problems to reduce aching, cramping, and tiredness in the hands and feet. It works by decreasing the thickness (viscosity) of blood. This change allows your blood to flow more easily, especially in the small blood vessels of the hands and feet. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
    [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".