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  4. NDC Product Code: 43063-532 Diethylpropion Hydrochloride ER

NDC 43063-532 Diethylpropion Hydrochloride ER

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

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 43063-532?
  5. Diethylpropion Hydrochloride ER Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
43063-532
Proprietary Name:
Diethylpropion Hydrochloride ER
Non-Proprietary Name: [1]
Diethylpropion Hydrochloride
Substance Name: [2]
Diethylpropion Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Pd-rx Pharmaceuticals, Inc.
    Labeler Code:
    43063
    Product Label ID:
    0d213a24-ebbf-41df-8f32-de44a572829e
    FDA Application Number: [6]
    ANDA091680
    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]
    10-24-2011
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325)
    Shape:
    OVAL (C48345)
    Size(s):
    19 MM
    Imprint(s):
    LCI;1477
    Score:
    1

    Product Packages

    NDC Code 43063-532-07

    Package Description: 7 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

    NDC Code 43063-532-14

    Package Description: 14 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

    NDC Code 43063-532-21

    Package Description: 21 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

    NDC Code 43063-532-28

    Package Description: 28 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

    NDC Code 43063-532-30

    Package Description: 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

    Product Details

    What is NDC 43063-532?

    The NDC code 43063-532 is assigned by the FDA to the product Diethylpropion Hydrochloride ER which is a human prescription drug product labeled by Pd-rx Pharmaceuticals, Inc.. The product's dosage form is tablet, extended release and is administered via oral form. The product is distributed in 5 packages with assigned NDC codes 43063-532-07 7 tablet, extended release in 1 bottle, plastic , 43063-532-14 14 tablet, extended release in 1 bottle, plastic , 43063-532-21 21 tablet, extended release in 1 bottle, plastic , 43063-532-28 28 tablet, extended release in 1 bottle, plastic , 43063-532-30 30 tablet, extended release 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 Diethylpropion Hydrochloride ER?

    Diethylpropion hydrochloride extended release tablets, 75 mg are indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of 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 divided by 2.2 = kg; inches x 0.0254 = meters. Body Mass Index (BMI), kg/m 2Weight (pounds) Height (feet, inches)5’0”5’3”5’6”5’9”6’0”6’3”140272523211918150292724222019160312826242220170333028252321180353229272523190373431282624200393632302725210413734312926220433936333028230454137343129240474339363330250494440373431The usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below. Diethylpropion hydrochloride extended release tablets, 75 mg are indicated for use as monotherapy only.

    What are Diethylpropion Hydrochloride ER 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.
    • DIETHYLPROPION HYDROCHLORIDE 75 mg/1 - A appetite depressant considered to produce less central nervous system disturbance than most drugs in this therapeutic category. It is also considered to be among the safest for patients with hypertension. (From AMA Drug Evaluations Annual, 1994, p2290)

    Which are Diethylpropion Hydrochloride ER UNII Codes?

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

    Which are Diethylpropion Hydrochloride ER 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 Diethylpropion Hydrochloride ER?

    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: 978668 - diethylpropion HCl 75 MG 24HR Extended Release Oral Tablet
    • RxCUI: 978668 - 24 HR diethylpropion hydrochloride 75 MG Extended Release Oral Tablet
    • RxCUI: 978668 - diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral Tablet

    Which are the Pharmacologic Classes for Diethylpropion Hydrochloride ER?

    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

    Diethylpropion


    Diethylpropion decreases appetite. It is used on a short-term basis (a few weeks), in combination with diet, to help you lose weight. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
    [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".