NDC Package 43353-610-70 Buspirone Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Package Information
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Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:

43353-610-70

Package Description:

120 TABLET in 1 BOTTLE, PLASTIC

Product Code:

43353-610

Proprietary Name:

Buspirone Hydrochloride

Usage Information:

Buspirone hydrochloride tablets are indicated for the management of anxiety disorders 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 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 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:•Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle.•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.•Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.•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 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 for 1 year without ill effect. Therefore, the physician who elects to use buspirone for extended periods should periodically reassess the usefulness of the drug for the individual patient.

11-Digit NDC Billing Format:

43353061070

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

120 EA

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

RxCUI: 866083 - busPIRone HCl 10 MG Oral Tablet

RxCUI: 866083 - buspirone hydrochloride 10 MG Oral Tablet

Labeler Name:

Aphena Pharma Solutions - Tennessee, Llc

Sample Package:

Start Marketing Date:

03-21-2002

Listing Expiration Date:

12-31-2019

Exclude Flag:

Code Structure:

43353 - Aphena Pharma Solutions - Tennessee, Llc
- 43353-610 - Buspirone Hydrochloride
  - 43353-610-70 - 120 TABLET in 1 BOTTLE, PLASTIC

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 Code	Package Description
43353-610-53	60 TABLET in 1 BOTTLE, PLASTIC
43353-610-60	90 TABLET in 1 BOTTLE, PLASTIC
43353-610-80	180 TABLET in 1 BOTTLE, PLASTIC
43353-610-92	270 TABLET in 1 BOTTLE, PLASTIC

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 43353-610-70?

The NDC Packaged Code 43353-610-70 is assigned to a package of 120 tablet in 1 bottle, plastic of Buspirone Hydrochloride, labeled by Aphena Pharma Solutions - Tennessee, Llc. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 120 billable units per package.

Is NDC 43353-610 included in the NDC Directory?

No, Buspirone Hydrochloride with product code 43353-610 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Aphena Pharma Solutions - Tennessee, Llc on March 21, 2002 and its listing in the NDC Directory is set to expire on December 31, 2019 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 43353-610-70?

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 120.

What is the 11-digit format for NDC 43353-610-70?

The 11-digit format is 43353061070. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	43353-610-70	5-4-2	43353-0610-70

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