NDC 53489-676 Phentermine Hydrochloride

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

Product Information

NDC Product Code:
53489-676
Proprietary Name:
Phentermine Hydrochloride
Non-Proprietary Name: [1]
Phentermine Hydrochloride
Substance Name: [2]
Phentermine Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Sun Pharmaceutical Industries, Inc.
    Labeler Code:
    53489
    FDA Application Number: [6]
    ANDA040526
    DEA Schedule: [7]
    Schedule IV (CIV) Substances
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    08-12-2013
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - WITH BLUE SPECKS)
    Shape:
    OVAL (C48345)
    Size(s):
    13 MM
    Imprint(s):
    MP;273
    Score:
    2

    Product Packages

    NDC Code 53489-676-01

    Package Description: 100 TABLET in 1 BOTTLE, PLASTIC

    Price per Unit: $0.08277 per EA

    NDC Code 53489-676-03

    Package Description: 250 TABLET in 1 BOTTLE, PLASTIC

    NDC Code 53489-676-05

    Package Description: 500 TABLET in 1 BOTTLE, PLASTIC

    NDC Code 53489-676-06

    Package Description: 60 TABLET in 1 BOTTLE, PLASTIC

    NDC Code 53489-676-07

    Package Description: 30 TABLET in 1 BOTTLE, PLASTIC

    NDC Code 53489-676-10

    Package Description: 1000 TABLET in 1 BOTTLE, PLASTIC

    Price per Unit: $0.08277 per EA

    Product Details

    What is NDC 53489-676?

    The NDC code 53489-676 is assigned by the FDA to the product Phentermine Hydrochloride which is a human prescription drug product labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is tablet and is administered via oral form. The product is distributed in 6 packages with assigned NDC codes 53489-676-01 100 tablet in 1 bottle, plastic , 53489-676-03 250 tablet in 1 bottle, plastic , 53489-676-05 500 tablet in 1 bottle, plastic , 53489-676-06 60 tablet in 1 bottle, plastic , 53489-676-07 30 tablet in 1 bottle, plastic , 53489-676-10 1000 tablet in 1 bottle, plastic . 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 Phentermine Hydrochloride?

    Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2, or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).Below is a chart of body mass index (BMI) based on various heights and weights.BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters.BODY MASS INDEX (BMI), kg/m2The limited usefulness of agents of this class, including phentermine hydrochloride tablets, [see Clinical Pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below.

    What are Phentermine 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.
    • PHENTERMINE HYDROCHLORIDE 30 mg/1 - A central nervous system stimulant and sympathomimetic with actions and uses similar to those of DEXTROAMPHETAMINE. It has been used most frequently in the treatment of obesity.

    Which are Phentermine Hydrochloride UNII Codes?

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

    Which are Phentermine 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:

    Which are the Pharmacologic Classes for Phentermine 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.

    * Please review the disclaimer below.

    Patient Education

    Phentermine


    Phentermine is used for a limited period of time to speed weight loss in overweight people who are exercising and eating a low-calorie diet. Phentermine is in a class of medications called anorectics. It works by decreasing appetite.
    [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.

    [7] What is the Drug Enforcement Administration (DEA) CIV Schedule? - This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

    [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".