NDC 64764-310-07 Actoplus Met XR
Pioglitazone And Metformin Hydrochloride Tablet, Film Coated, Extended Release Oral

Package Information

The NDC Code 64764-310-07 is assigned to a package of 1 blister pack in 1 carton > 7 tablet, film coated, extended release in 1 blister pack of Actoplus Met XR, a human prescription drug labeled by Takeda Pharmaceuticals America, Inc.. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

Field Name Field Value
NDC Code 64764-310-07
Package Description 1 BLISTER PACK in 1 CARTON > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Product Code 64764-310
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Actoplus Met XR
Non-Proprietary Name 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.
Pioglitazone And Metformin Hydrochloride
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
This combination medication is used along with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Pioglitazone belongs to a class of drugs known as thiazolidinediones or "glitazones". Metformin and pioglitazone work by helping to restore your body's proper response to the insulin you naturally produce. Metformin also decreases the amount of sugar that your liver makes and that your stomach/intestines absorb. Talk to your doctor about the risks and benefits of using pioglitazone-containing products.
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
64764031007
NDC to RxNorm Crosswalk
  • RxCUI: 899989
  • RxCUI: 899993
  • RxCUI: 899996
  • RxCUI: 900000
  • Product Type 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.
    Human Prescription Drug
    Labeler Name Takeda Pharmaceuticals America, Inc.
    Dosage Form Tablet, Film Coated, Extended Release - 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; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.
    Administration Route(s)
    • Oral - Administration to or by way of the mouth.
    Active Ingredient(s)
    Pharmacologic Class(es)
    Sample Package Sample Package?
    This field Indicates whether this package is a sample packaging or not.
    No
    Marketing Category 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.
    NDA - A product marketed under an approved New Drug Application.
    FDA Application Number 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.
    NDA022024
    Start Marketing Date What is the Start Marketing Date?
    This is the date that the labeler indicates was the start of its marketing of the drug product.
    06-11-2010
    End Marketing Date What is the End Marketing Date?
    This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
    09-30-2022
    Exclude Flag 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".
    N
    NDC Code Structure

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for Actoplus Met with product NDC 64764-310.

    NDC Package CodePackage Description
    64764-310-3030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
    64764-310-3330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
    64764-310-6060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
    64764-310-9090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.