Olanzapine Pamoate Injection, Powder, For Suspension, Extended Release
NDC Package 71161-142-01

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Olanzapine Pamoate injection is olanzapine injection is used to treat a certain mental/mood disorder (schizophrenia). This formulation utilizes a injection, powder, for suspension, extended release delivery system. Marketed by Synergy Health Ast, Llc, this product is identified by NDC 71161-142.

Identification & Billing

NDC Package Code
71161-142-01
Package Description
1.4 mL in 1 VIAL
Product Code
71161-142
11-Digit Billing Format
71161014201

Clinical Specifications

Proprietary Name
Olanzapine Pamoate
Non-Proprietary Name
Olanzapine Pamoate
Substance Name
Olanzapine Pamoate
Dosage Form
Injection, Powder, For Suspension, Extended Release - A dried preparation intended for reconstitution to form a suspension for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution).
Active Ingredient(s)
OLANZAPINE PAMOATE 210 mg/1.4mL
Usage Information
Olanzapine injection is used to treat a certain mental/mood disorder (schizophrenia). Olanzapine helps you to think more clearly, feel less nervous, and take part in everyday life. It may also help to decrease hallucinations (hearing/seeing things that are not there). Extended-release olanzapine injection is a long-acting psychiatric medication called an atypical antipsychotic. It works by helping to restore the balance of certain natural substances in the brain. Talk to the doctor about the risks and benefits of treatment (especially when used in teenagers). See also Warning/Precautions sections.

Regulatory & Marketing

Labeler Name
Synergy Health Ast, Llc
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
12-11-2009
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 71161-142-01 identifies a specific commercial package of 1.4 ml in 1 vial of Olanzapine Pamoate (UNFINISHED drug), drug for further processing labeled by Synergy Health Ast, Llc. This injection, powder, for suspension, extended release is formulated for use and contains olanzapine pamoate 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 Synergy Health Ast, Llc on December 11, 2009. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Olanzapine injection is used to treat a certain mental/mood disorder (schizophrenia). Olanzapine helps you to think more clearly, feel less nervous, and take part in everyday life. It may also help to decrease hallucinations (hearing/seeing things that are not there). Extended-release olanzapine injection is a long-acting psychiatric medication called an atypical antipsychotic. It works by helping to restore the balance of certain natural substances in the brain. Talk to the doctor about the risks and benefits of treatment (especially when used in teenagers). See also Warning/Precautions sections.

How is this Synergy Health Ast, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71161014201. 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)
71161-142-01
11-Digit CMS (5-4-2)
71161-0142-01

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