NDC 45802-402 Alogliptin And Pioglitazone

Alogliptin Benzoate And Pioglitazone Hydrochloride Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
45802-402
Proprietary Name:
Alogliptin And Pioglitazone
Non-Proprietary Name: [1]
Alogliptin Benzoate And Pioglitazone Hydrochloride
Substance Name: [2]
Alogliptin Benzoate; Pioglitazone Hydrochloride
NDC Directory Status:
Human Prescription 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 Code:
    45802
    FDA Application Number: [6]
    NDA022426
    Marketing Category: [8]
    NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
    Start Marketing Date: [9]
    04-08-2016
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    YELLOW (C48330 - PALE YELLOW)
    ORANGE (C48331 - PALE PEACH)
    RED (C48326 - PALE RED)
    YELLOW (C48330)
    RED (C48326)
    ORANGE (C48331 - PEACH)
    Shape:
    ROUND (C48348)
    Size(s):
    9 MM
    Imprint(s):
    AP;12;5;15
    AP;12;5;30
    AP;12;5;45
    AP;25;15
    AP;25;45
    AP;25;30
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 45802-402?

    The NDC code 45802-402 is assigned by the FDA to the product Alogliptin And Pioglitazone which is a human prescription drug product labeled by Padagis Israel Pharmaceuticals Ltd. The generic name of Alogliptin And Pioglitazone is alogliptin benzoate and pioglitazone hydrochloride. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in a single package with assigned NDC code 45802-402-65 30 tablet, film coated 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 Alogliptin And Pioglitazone?

    History of a serious hypersensitivity reaction to alogliptin or pioglitazone, components of alogliptin and pioglitazone tablets, such as anaphylaxis, angioedema or severe cutaneous adverse reactions.Do not initiate in patients with NYHA Class III or IV heart failure [see Boxed Warning].

    What are Alogliptin And Pioglitazone 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 Alogliptin And Pioglitazone UNII Codes?

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

    Which are Alogliptin And Pioglitazone 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 Alogliptin And Pioglitazone?

    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: 1368403 - alogliptin 12.5 MG / pioglitazone 15 MG Oral Tablet
    • RxCUI: 1368403 - alogliptin 12.5 MG (as alogliptin benzoate 17 MG) / pioglitazone 15 MG (as pioglitazone hydrochloride 16.53 MG) Oral Tablet
    • RxCUI: 1368410 - alogliptin 12.5 MG / pioglitazone 30 MG Oral Tablet
    • RxCUI: 1368410 - alogliptin 12.5 MG (as alogliptin benzoate 17 MG) / pioglitazone 30 MG (as pioglitazone hydrochloride 33.06 MG) Oral Tablet
    • RxCUI: 1368417 - alogliptin 12.5 MG / pioglitazone 45 MG Oral Tablet

    Which are the Pharmacologic Classes for Alogliptin And Pioglitazone?

    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.

    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".