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  4. NDC Product Code: 52389-249 Diurex Max

NDC 52389-249 Diurex Max

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

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 52389-249?
  5. Diurex Max Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
52389-249
Proprietary Name:
Diurex Max
Non-Proprietary Name: [1]
Pamabrom
Substance Name: [2]
Pamabrom
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated - 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.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Alva-amco Pharmacal Companies, Inc.
    Labeler Code:
    52389
    Product Label ID:
    37dfece3-d570-4ab2-ba95-af6eb1f3acd4
    FDA Application Number: [6]
    M027
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    12-20-1995
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    BLUE (C48333)
    Shape:
    OVAL (C48345)
    Size(s):
    15 MM
    Imprint(s):
    ALVA;1
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 52389-249?

    The NDC code 52389-249 is assigned by the FDA to the product Diurex Max which is a human over the counter drug product labeled by Alva-amco Pharmacal Companies, Inc.. The generic name of Diurex Max is pamabrom. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 6 packages with assigned NDC codes 52389-249-10 4 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack, 52389-249-24 1 blister pack in 1 carton / 24 tablet, film coated in 1 blister pack, 52389-249-30 3 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack, 52389-249-48 2 blister pack in 1 carton / 24 tablet, film coated in 1 blister pack, 52389-249-50 5 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack, 52389-249-72 3 blister pack in 1 carton / 24 tablet, film coated in 1 blister pack. 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 Diurex Max?

    Read all package directions and warnings before use.Use only as directed.Adults:  One (1) caplet after breakfast with a full glass of water.Dose may be repeated after 6 hours, not to exceed four (4) caplets in 24 hours.Start taking 5 or 6 days before onset of period and continue until desired relief is obtained or end of period.Drink 6 to 8 glasses of water daily.For use by normally healthy adults only.Persons under 18 years of age should use only as directed by a doctor.

    What are Diurex Max 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 Diurex Max UNII Codes?

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

    Which are Diurex Max 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 Diurex Max?

    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:

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    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".