NDC Package 53489-676-01 Phentermine Hydrochloride

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
53489-676-01
Package Description:
100 TABLET in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Phentermine Hydrochloride
Non-Proprietary Name:
Phentermine Hydrochloride
Substance Name:
Phentermine Hydrochloride
Usage Information:
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.
11-Digit NDC Billing Format:
53489067601
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
Product Type:
Human Prescription Drug
Labeler Name:
Sun Pharmaceutical Industries, 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):
    DEA Schedule:
    Schedule IV (CIV) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA040526
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    08-12-2013
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 this product:

    NDC Package CodePackage Description
    53489-676-03250 TABLET in 1 BOTTLE, PLASTIC
    53489-676-05500 TABLET in 1 BOTTLE, PLASTIC
    53489-676-0660 TABLET in 1 BOTTLE, PLASTIC
    53489-676-0730 TABLET in 1 BOTTLE, PLASTIC
    53489-676-101000 TABLET in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 53489-676-01?

    The NDC Packaged Code 53489-676-01 is assigned to a package of 100 tablet in 1 bottle, plastic of Phentermine Hydrochloride, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 53489-676 included in the NDC Directory?

    Yes, Phentermine Hydrochloride with product code 53489-676 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on August 12, 2013 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 53489-676-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 53489-676-01?

    The 11-digit format is 53489067601. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-253489-676-015-4-253489-0676-01