NDC 68084-288 Fludrocortisone Acetate

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

Product Information

NDC Product Code:
68084-288
Proprietary Name:
Fludrocortisone Acetate
Non-Proprietary Name: [1]
Fludrocortisone Acetate
Substance Name: [2]
Fludrocortisone Acetate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    American Health Packaging
    Labeler Code:
    68084
    FDA Application Number: [6]
    ANDA040431
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    09-09-2008
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - WHITE TO OFF-WHITE)
    Shape:
    ROUND (C48348)
    Size(s):
    6 MM
    Imprint(s):
    7033
    Score:
    2

    Product Packages

    NDC Code 68084-288-01

    Package Description: 100 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET in 1 BLISTER PACK (68084-288-11)

    Price per Unit: $0.41855 per EA

    NDC Code 68084-288-65

    Package Description: 50 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (68084-288-11)

    Price per Unit: $0.41855 per EA

    Product Details

    What is NDC 68084-288?

    The NDC code 68084-288 is assigned by the FDA to the product Fludrocortisone Acetate which is a human prescription drug product labeled by American Health Packaging. The product's dosage form is tablet and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 68084-288-01 100 blister pack in 1 box, unit-dose / 1 tablet in 1 blister pack (68084-288-11), 68084-288-65 50 blister pack in 1 carton / 1 tablet in 1 blister pack (68084-288-11). 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 Fludrocortisone Acetate?

    Fludrocortisone is a man-made form of a natural substance (glucocorticoid) made by the body. It is used along with other medications (e.g., hydrocortisone) to treat low glucocorticoid levels caused by disease of the adrenal gland (e.g., Addison's disease, adrenocortical insufficiency, salt-losing adrenogenital syndrome). Glucocorticoids are needed in many ways for the body to function well. They are important for salt and water balance and keeping blood pressure normal. They are also needed to break down carbohydrates in your diet.

    What are Fludrocortisone Acetate 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 Fludrocortisone Acetate UNII Codes?

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

    Which are Fludrocortisone Acetate 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 Fludrocortisone Acetate?

    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:

    * Please review the disclaimer below.

    Patient Education

    Fludrocortisone Acetate


    Fludrocortisone, a corticosteroid, is used to help control the amount of sodium and fluids in your body. It is used to treat Addison's disease and syndromes where excessive amounts of sodium are lost in the urine. It works by decreasing the amount of sodium that is lost (excreted) in your urine. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
    [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".