Aripiprazole
NDC Package 50436-0897-1
Package Information
Aripiprazole is used to treat certain mental/mood disorders (such as bipolar disorder, schizophrenia, Tourette's syndrome, and irritability associated with autistic disorder). Marketed by Unit Dose Services, this product is identified by NDC 50436-0897 and is authorized under FDA application ANDA204838.
Identification & Billing
- RxCUI: 402131 - ARIPiprazole 5 MG Oral Tablet
- RxCUI: 402131 - aripiprazole 5 MG Oral Tablet
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 50436 - Unit Dose Services
- 50436-0897 - Aripiprazole
- 50436-0897-1 - 50 POUCH in 1 BOX, UNIT-DOSE / 1 TABLET in 1 POUCH
- 50436-0897 - Aripiprazole
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 50436-0897-1 identifies a specific commercial package of 50 pouch in 1 box, unit-dose / 1 tablet in 1 pouch of Aripiprazole, labeled by Unit Dose Services. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Unit Dose Services on June 20, 2016. The current certification is valid through December 31, 2020.
What are the primary indications for this medication?
Aripiprazole is used to treat certain mental/mood disorders (such as bipolar disorder, schizophrenia, Tourette's syndrome, and irritability associated with autistic disorder). It may also be used in combination with other medication to treat depression. Aripiprazole is known as an antipsychotic drug (atypical type). It works by helping to restore the balance of certain natural chemicals in the brain (neurotransmitters). This medication can decrease hallucinations and improve your concentration. It helps you to think more clearly and positively about yourself, feel less nervous, and take a more active part in everyday life. Aripiprazole can treat severe mood swings and decrease how often mood swings occur.
How is this Unit Dose Services product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436089701. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.