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  5. NDC Package Code: 43547-404-03 Phentermine Hydrochloride

NDC Package 43547-404-03 Phentermine Hydrochloride

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

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

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:
43547-404-03
Package Description:
30 TABLET in 1 BOTTLE, PLASTIC
Product Code:
43547-404
Proprietary Name:
Phentermine Hydrochloride
Non-Proprietary Name:
Phentermine Hydrochloride
Substance Name:
Phentermine Hydrochloride
Usage Information:
Phentermine hydrochloride tablets, USP are 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 x 0.0254 = meters.The limited usefulness of agents of this class, including phentermine hydrochloride tablets, USP [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:
43547040403
NDC to RxNorm Crosswalk:
  • RxCUI: 803353 - phentermine HCl 37.5 MG Oral Tablet
  • RxCUI: 803353 - phentermine hydrochloride 37.5 MG Oral Tablet
  • RxCUI: 803353 - phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Solco Healthcare U.s., Llc
    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):
  • PHENTERMINE HYDROCHLORIDE 37.5 mg/1
    • Pharmacologic Class(es):
  • Appetite Suppression - [PE] (Physiologic Effect)
  • Increased Sympathetic Activity - [PE] (Physiologic Effect)
  • Sympathomimetic Amine Anorectic - [EPC] (Established Pharmacologic Class)
    • DEA Schedule:
    Schedule IV (CIV) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA040377
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    01-04-2002
    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
    43547-404-10100 TABLET in 1 BOTTLE, PLASTIC
    43547-404-111000 TABLET in 1 BOTTLE, PLASTIC

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 43547-404-03?

    The NDC Packaged Code 43547-404-03 is assigned to a package of 30 tablet in 1 bottle, plastic of Phentermine Hydrochloride, a human prescription drug labeled by Solco Healthcare U.s., Llc. The product's dosage form is tablet and is administered via oral form.

    Is NDC 43547-404 included in the NDC Directory?

    Yes, Phentermine Hydrochloride with product code 43547-404 is active and included in the NDC Directory. The product was first marketed by Solco Healthcare U.s., Llc on January 04, 2002 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 11-digit format for NDC 43547-404-03?

    The 11-digit format is 43547040403. 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
    5-3-243547-404-035-4-243547-0404-03