NDC Package 55700-869-90 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 discontinued by the firm.

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:

55700-869-90

Package Description:

90 TABLET in 1 BOTTLE, PLASTIC

Product Code:

55700-869

Proprietary Name:

Buspirone Hydrochloride

Usage Information:

Buspirone hydrochloride tablets, USP 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 tablets, USP 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, USP 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 hydrochloride tablets, USP 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, USP for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets, USP for extended periods should periodically reassess the usefulness of the drug for the individual patient.

11-Digit NDC Billing Format:

55700086990

Labeler Name:

Quality Care Products, Llc

Sample Package:

FDA Application Number:

ANDA210907

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

06-11-2020

End Marketing Date:

09-30-2024

Listing Expiration Date:

09-30-2024

Exclude Flag:

Code Structure:

55700 - Quality Care Products, Llc
- 55700-869 - Buspirone Hydrochloride
  - 55700-869-90 - 90 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
55700-869-60	60 TABLET in 1 BOTTLE, PLASTIC

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 55700-869-90?

The NDC Packaged Code 55700-869-90 is assigned to a package of 90 tablet in 1 bottle, plastic of Buspirone Hydrochloride, labeled by Quality Care Products, Llc. The product's dosage form is and is administered via form.

Is NDC 55700-869 included in the NDC Directory?

No, Buspirone Hydrochloride with product code 55700-869 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Quality Care Products, Llc on June 11, 2020 and its listing in the NDC Directory is set to expire on September 30, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 55700-869-90?

The 11-digit format is 55700086990. 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	55700-869-90	5-4-2	55700-0869-90

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