NDC 65862-010 Metformin Hydrochloride

Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
65862-010
Proprietary Name:
Metformin Hydrochloride
Non-Proprietary Name: [1]
Metformin Hydrochloride
Substance Name: [2]
Metformin 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 Name: [5]
    Aurobindo Pharma Limited
    Labeler Code:
    65862
    FDA Application Number: [6]
    ANDA077095
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    01-14-2005
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Shape:
    ROUND (C48348)
    OVAL (C48345)
    Size(s):
    11 MM
    13 MM
    19 MM
    Imprint(s):
    A;12
    A;13
    1;4;A
    Score:
    1
    2

    Product Packages

    NDC Code 65862-010-01

    Package Description: 100 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $0.02348 per EA

    NDC Code 65862-010-05

    Package Description: 500 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $0.02348 per EA

    NDC Code 65862-010-15

    Package Description: 1500 TABLET, FILM COATED in 1 BAG

    NDC Code 65862-010-22

    Package Description: 2000 TABLET, FILM COATED in 1 BAG

    NDC Code 65862-010-27

    Package Description: 27000 TABLET, FILM COATED in 1 BAG

    NDC Code 65862-010-33

    Package Description: 300 TABLET, FILM COATED in 1 BOTTLE

    NDC Code 65862-010-46

    Package Description: 2000 TABLET, FILM COATED in 1 BOTTLE

    NDC Code 65862-010-50

    Package Description: 50 TABLET, FILM COATED in 1 BOTTLE

    NDC Code 65862-010-60

    Package Description: 60 TABLET, FILM COATED in 1 BOTTLE

    NDC Code 65862-010-90

    Package Description: 90 TABLET, FILM COATED in 1 BOTTLE

    NDC Code 65862-010-99

    Package Description: 1000 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $0.02348 per EA

    Product Details

    What is NDC 65862-010?

    The NDC code 65862-010 is assigned by the FDA to the product Metformin Hydrochloride which is a human prescription drug product labeled by Aurobindo Pharma Limited. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 11 packages with assigned NDC codes 65862-010-01 100 tablet, film coated in 1 bottle , 65862-010-05 500 tablet, film coated in 1 bottle , 65862-010-15 1500 tablet, film coated in 1 bag , 65862-010-22 2000 tablet, film coated in 1 bag , 65862-010-27 27000 tablet, film coated in 1 bag , 65862-010-33 300 tablet, film coated in 1 bottle , 65862-010-46 2000 tablet, film coated in 1 bottle , 65862-010-50 50 tablet, film coated in 1 bottle , 65862-010-60 60 tablet, film coated in 1 bottle , 65862-010-90 90 tablet, film coated in 1 bottle , 65862-010-99 1000 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 Metformin Hydrochloride?

    Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.

    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 1000 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)
    • METFORMIN HYDROCHLORIDE 1000 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)

    Which are Metformin Hydrochloride UNII Codes?

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

    Which are Metformin Hydrochloride 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 Metformin Hydrochloride?

    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:

    Which are the Pharmacologic Classes for Metformin Hydrochloride?

    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

    Amlodipine


    Amlodipine is used alone or in combination with other medications to treat high blood pressure in adults and children 6 years and older. It is also used to treat certain types of angina (chest pain) and coronary artery disease (narrowing of the blood vessels that supply blood to the heart). Amlodipine is in a class of medications called calcium channel blockers. It lowers blood pressure by relaxing the blood vessels so the heart does not have to pump as hard. It controls chest pain by increasing the supply of blood to the heart. If taken regularly, amlodipine controls chest pain, but it does not stop chest pain once it starts. Your doctor may prescribe a different medication to take when you have chest pain. High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.
    [Learn More]


    * 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".