NDC 64764-310-60 Actoplus Met XR

Pioglitazone And Metformin Hydrochloride

NDC Package Code 64764-310-60

The NDC Code 64764-310-60 is assigned to a package of 60 tablet, film coated, extended release in 1 bottle, plastic 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 64764-310-60
Package Description 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Proprietary Name Actoplus Met XR 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.
Non-Proprietary Name Pioglitazone And Metformin Hydrochloride 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.
Drug Uses 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 64764031060 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.
RxNorm Crosswalk899989, 899993, 899996 and 900000 - RxCUIs What is RxNorm?
The RxNorm crosswalk provides a normalized naming system for generic and branded drugs by assigning unique concept identifiers (RxCUI) to each NDC.
Product Type Human Prescription Drug 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.
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)
  • PIOGLITAZONE HYDROCHLORIDE 30 mg/1
  • METFORMIN HYDROCHLORIDE 1000 mg/1
Pharmacological Class(es)
  • Peroxisome Proliferator-activated Receptor Activity - [MoA] (Mechanism of Action)
  • PPAR alpha - [CS]
  • PPAR gamma - [CS]
  • Thiazolidinedione - [EPC] (Established Pharmacologic Class)
  • Thiazolidinediones - [CS]
  • Peroxisome Proliferator Receptor alpha Agonist - [EPC] (Established Pharmacologic Class)
  • Peroxisome Proliferator Receptor gamma Agonist - [EPC] (Established Pharmacologic Class)
  • Biguanide - [EPC] (Established Pharmacologic Class)
  • Biguanides - [CS]
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category NDA - A product marketed under an approved New Drug Application. 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.
FDA Application Number NDA022024 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.
Start Marketing Date 06-11-2010 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
End Marketing Date 09-30-2022 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.
Exclude Flag N 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".

NDC Code Structure

  • 64764 - Takeda Pharmaceuticals America, Inc.
    • 64764-310 - Actoplus Met
      • 64764-310-60 - 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

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
64764-310-071 BLISTER PACK in 1 CARTON > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
64764-310-3030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
64764-310-3330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
64764-310-9090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

* Please review the disclaimer below.