Olanzapine
NDC Package 48792-7828-1

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 EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Olanzapine is used to treat certain mental/mood conditions (such as schizophrenia, bipolar disorder). Marketed by Sunshine Lake Pharma Co., Ltd., this product is identified by NDC 48792-7828 and is authorized under FDA application ANDA206238.

Identification & Billing

NDC Package Code
48792-7828-1
Package Description
30 TABLET in 1 BOTTLE, PLASTIC
Product Code
48792-7828
11-Digit Billing Format
48792782801

Clinical Specifications

Proprietary Name
Olanzapine
Dosage Form
-
Usage Information
Olanzapine is used to treat certain mental/mood conditions (such as schizophrenia, bipolar disorder). It may also be used in combination with other medication to treat depression. This medication can help to decrease hallucinations and help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life. Olanzapine belongs to a class of drugs called atypical antipsychotics. 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 by teenagers). See also Precautions section.

Regulatory & Marketing

Labeler Name
Sunshine Lake Pharma Co., Ltd.
FDA Application #
ANDA206238
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-30-2018
End Marketing Date
11-30-2018
Listing Expiration
11-30-2018
Exclude Flag
D
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 48792-7828-1 identifies a specific commercial package of 30 tablet in 1 bottle, plastic of Olanzapine, labeled by Sunshine Lake Pharma Co., Ltd.. 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 Sunshine Lake Pharma Co., Ltd. on November 30, 2018. The current certification is valid through November 30, 2018.

What are the primary indications for this medication?

Olanzapine is used to treat certain mental/mood conditions (such as schizophrenia, bipolar disorder). It may also be used in combination with other medication to treat depression. This medication can help to decrease hallucinations and help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life. Olanzapine belongs to a class of drugs called atypical antipsychotics. 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 by teenagers). See also Precautions section.

How is this Sunshine Lake Pharma Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48792782801. 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 (5-4-1)
48792-7828-1
11-Digit CMS (5-4-2)
48792-7828-01

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