NDC Package 71205-280-60 Buspirone 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:
71205-280-60
Package Description:
60 TABLET in 1 BOTTLE
Product Code:
Proprietary Name:
Buspirone Hydrochloride
Non-Proprietary Name:
Buspirone Hydrochloride
Substance Name:
Buspirone Hydrochloride
Usage Information:
Buspirone hydrochloride tablets are indicated for the management of anxiety disorder or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association's Diagnostic and Statistical Manual, III1 as follows:Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories:1.Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle.2.Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate.3.Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.4.Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD.The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long- term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.
11-Digit NDC Billing Format:
71205028060
NDC to RxNorm Crosswalk:
  • RxCUI: 866018 - busPIRone HCl 15 MG Oral Tablet
  • RxCUI: 866018 - buspirone hydrochloride 15 MG Oral Tablet
  • RxCUI: 866018 - buspirone hydrochloride 15 MG (buspirone 13.7 MG) Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Proficient Rx Lp
    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):
    Sample Package:
    No
    FDA Application Number:
    ANDA209696
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    07-03-2018
    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
    71205-280-3030 TABLET in 1 BOTTLE
    71205-280-9090 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 71205-280-60?

    The NDC Packaged Code 71205-280-60 is assigned to a package of 60 tablet in 1 bottle of Buspirone Hydrochloride, a human prescription drug labeled by Proficient Rx Lp. The product's dosage form is tablet and is administered via oral form.

    Is NDC 71205-280 included in the NDC Directory?

    Yes, Buspirone Hydrochloride with product code 71205-280 is active and included in the NDC Directory. The product was first marketed by Proficient Rx Lp on July 03, 2018 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 71205-280-60?

    The 11-digit format is 71205028060. 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
    5-3-271205-280-605-4-271205-0280-60