Opipza Film, Soluble
NDC Package 15370-403-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Opipza (aripiprazole) films is aripiprazole is used to treat certain mental/mood disorders (such as bipolar disorder, schizophrenia, Tourette's syndrome, and irritability associated with autistic disorder). This formulation utilizes a film, soluble delivery system. Marketed by Carwin Pharmaceutical Associates, Llc, this product is identified by NDC 15370-403 and is authorized under FDA application NDA216655.

Identification & Billing

NDC Package Code
15370-403-30
Package Description
30 POUCH in 1 CARTON / 1 FILM, SOLUBLE in 1 POUCH (15370-403-01)
Product Code
15370-403
11-Digit Billing Format
15370040330
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Opipza
Non-Proprietary Name
Aripiprazole
Substance Name
Aripiprazole
Dosage Form
Film, Soluble - A thin layer or coating which is susceptible to being dissolved when in contact with a liquid.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ARIPIPRAZOLE 10 mg/1
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
Usage Information
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.

Regulatory & Marketing

Labeler Name
Carwin Pharmaceutical Associates, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA216655
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
11-01-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 15370-403-30 identifies a specific commercial package of 30 pouch in 1 carton / 1 film, soluble in 1 pouch (15370-403-01) of Opipza, a human prescription drug labeled by Carwin Pharmaceutical Associates, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This film, soluble is formulated for oral use and contains aripiprazole as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Carwin Pharmaceutical Associates, Llc on November 01, 2024. The current certification is valid through December 31, 2026.

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 Carwin Pharmaceutical Associates, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 15370040330. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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:

10-Digit Format (5-3-2)
15370-403-30
11-Digit CMS (5-4-2)
15370-0403-30

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.