Olanzapine Tablet, Film Coated
NDC Package 87383-005-00

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 tablets is olanzapine is used to treat certain mental/mood conditions (such as schizophrenia, bipolar disorder). This formulation utilizes a tablet, film coated delivery system. Marketed by Fidelio Healthcare Limburg Gmbh, this product is identified by NDC 87383-005.

Identification & Billing

NDC Package Code
87383-005-00
Package Description
30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code
87383-005
11-Digit Billing Format
87383000500

Clinical Specifications

Proprietary Name
Olanzapine
Non-Proprietary Name
Olanzapine
Substance Name
Olanzapine
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Active Ingredient(s)
OLANZAPINE 2.5 mg/1
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
Fidelio Healthcare Limburg Gmbh
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
02-01-2026
Listing Expiration
12-31-2027
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 87383-005-00 identifies a specific commercial package of 30 tablet, film coated in 1 bottle, plastic of Olanzapine (UNFINISHED drug), drug for further processing labeled by Fidelio Healthcare Limburg Gmbh. This tablet, film coated is formulated for use and contains olanzapine 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 Fidelio Healthcare Limburg Gmbh on February 01, 2026. The current certification is valid through December 31, 2027.

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 Fidelio Healthcare Limburg Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 87383000500. 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)
87383-005-00
11-Digit CMS (5-4-2)
87383-0005-00

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