NDC 64764-301-02 Actos

Pioglitazone

NDC Package Code 64764-301-02

The NDC Code 64764-301-02 is assigned to a package of 6 carton in 1 tray > 1 blister pack in 1 carton > 7 tablet in 1 blister pack of Actos, a human prescription drug labeled by Takeda Pharmaceuticals America, Inc.. The product's dosage form is tablet and is administered via oral form.

Field Name Field Value
NDC Code 64764-301-02
Package Description 6 CARTON in 1 TRAY > 1 BLISTER PACK in 1 CARTON > 7 TABLET in 1 BLISTER PACK
Proprietary Name Actos 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 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 Pioglitazone is a diabetes drug (thiazolidinedione-type, also called "glitazones") used along with a proper diet and exercise program to control high blood sugar in patients with type 2 diabetes. It works by helping to restore your body's proper response to insulin, thereby lowering your blood sugar. 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 is used either alone or in combination with other diabetes medications (such as metformin or a sulfonylurea such as glyburide). Talk to your doctor about the risks and benefits of pioglitazone.
11-Digit NDC Billing Format 64764030102 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 Crosswalk261266, 261267, 261268, 312440, 312441 and 317573 - 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 - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s)
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
  • PIOGLITAZONE HYDROCHLORIDE 30 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)
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 NDA021073 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 07-15-1999 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2022 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.
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.
    • 64764-301 - Actos
      • 64764-301-02 - 6 CARTON in 1 TRAY

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 Actos with product NDC 64764-301.

NDC Package CodePackage Description
64764-301-1430 TABLET in 1 BOTTLE
64764-301-1590 TABLET in 1 BOTTLE
64764-301-16500 TABLET in 1 BOTTLE

* Please review the disclaimer below.