NDC 62135-330 Prednisolone Sodium Phosphate

Solution Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
62135-330
Proprietary Name:
Prednisolone Sodium Phosphate
Non-Proprietary Name: [1]
Prednisolone Sodium Phosphate
Substance Name: [2]
Prednisolone Sodium Phosphate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Chartwell Rx, Llc.
    Labeler Code:
    62135
    FDA Application Number: [6]
    ANDA075988
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    05-25-2004
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Flavor(s):
    RASPBERRY (C73413)

    Product Packages

    NDC Code 62135-330-41

    Package Description: 120 mL in 1 BOTTLE

    Price per Unit: $0.55508 per ML

    Product Details

    What is NDC 62135-330?

    The NDC code 62135-330 is assigned by the FDA to the product Prednisolone Sodium Phosphate which is a human prescription drug product labeled by Chartwell Rx, Llc.. The product's dosage form is solution and is administered via oral form. The product is distributed in a single package with assigned NDC code 62135-330-41 120 ml 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 Prednisolone Sodium Phosphate?

    Prednisolone is a man-made form of a natural substance (corticosteroid hormone) made by the adrenal gland. It is used to treat conditions such as arthritis, blood problems, immune system disorders, skin and eye conditions, breathing problems, cancer, and severe allergies. It decreases your immune system's response to various diseases to reduce symptoms such as pain, swelling and allergic-type reactions.

    What are Prednisolone Sodium Phosphate 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 Prednisolone Sodium Phosphate UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Prednisolone Sodium Phosphate?

    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: 312614 - prednisoLONE sodium phosphate 5 MG in 5 mL Oral Solution
    • RxCUI: 312614 - prednisolone 1 MG/ML Oral Solution
    • RxCUI: 312614 - prednisolone 5 MG (as prednisolone sodium phosphate 6.7 MG) per 5 ML Oral Solution

    Which are the Pharmacologic Classes for Prednisolone Sodium Phosphate?

    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

    Prednisolone


    Prednisolone is used alone or with other medications to treat the symptoms of low corticosteroid levels (lack of certain substances that are usually produced by the body and are needed for normal body functioning). Prednisolone is also used to treat certain conditions that affect the blood, skin, eyes, central nervous system, kidneys, lungs, stomach, and intestines. It is also used to treat allergic reactions; and certain types of arthritis; multiple sclerosis (a disease in which the nerves do not function properly); and to help prevent transplant rejection (attack of the transplanted organ by the body) in certain adults who have received a transplant. Prednisolone is also sometimes used to treat symptoms from certain types of cancer. Prednisolone is in a class of medications called corticosteroids. It works by reducing swelling and redness and by changing the way the immune system works.
    [Learn More]


    Steroids


    You may have heard of anabolic steroids, which can have harmful effects. But there's another type of steroid - sometimes called a corticosteroid - that treats a variety of problems. These steroids are similar to hormones that your adrenal glands make to fight stress associated with illnesses and injuries. They reduce inflammation and affect the immune system.

    You may need to take corticosteroids to treat:

    • Arthritis
    • Asthma
    • Autoimmune diseases such as lupus and multiple sclerosis
    • Skin conditions such as eczema and rashes
    • Some kinds of cancer

    Steroids are strong medicines, and they can have side effects, including weakened bones and cataracts. Because of this, you usually take them for as short a time as possible.


    [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".