NDC 0591-2719 Metformin Hydrochloride
Tablet, Film Coated, Extended Release Oral

Product Information

Metformin Hydrochloride is a human prescription drug product labeled by Actavis Pharma, Inc.. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

Product Code0591-2719
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.
Metformin Hydrochloride
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.
Metformin Hydrochloride
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
Dosage FormTablet, 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) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Actavis Pharma, Inc.
Labeler Code0591
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.
NDA021574
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 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 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
04-18-2012
Listing Expiration Date 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.
12-31-2023
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

What are the uses for Metformin Hydrochloride?


Product Characteristics

Color(s)WHITE (C48325)
ShapeROUND (C48348)
Size(s)12 MM
Imprint(s)574
Score1

Product Packages

NDC 0591-2719-60

Package Description: 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

Price per Unit: $0.62678 per EA

Product Details

What are Metformin Hydrochloride 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.
  • METFORMIN HYDROCHLORIDE 500 mg/1 - A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)

NDC to RxNorm Crosswalk

What is RxNorm? 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: 1807894 - metFORMIN HCl 1000 MG Osmotic 24HR Extended Release Oral Tablet
  • RxCUI: 1807894 - Osmotic 24 HR metformin hydrochloride 1000 MG Extended Release Oral Tablet
  • RxCUI: 1807894 - metformin HCl 1000 MG Osmotic 24 HR Extended Release Oral Tablet
  • RxCUI: 1807917 - metFORMIN HCl 500 MG Osmotic 24HR Extended Release Oral Tablet
  • RxCUI: 1807917 - Osmotic 24 HR metformin hydrochloride 500 MG Extended Release Oral Tablet

Inactive Ingredient(s)

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.
  • CELLULOSE ACETATE (UNII: 3J2P07GVB6)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POVIDONE (UNII: FZ989GH94E)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)

Pharmacologic Class(es)

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.

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Patient Education

Metformin

Metformin is pronounced as (met for' min)

Why is metformin medication prescribed?
Metformin is used alone or with other medications, including insulin, to treat type 2 diabetes (condition in which the body does not use insulin normally and, therefore, ...
[Read More]

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Metformin Hydrochloride Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

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