Olanzapine Tablet, Film Coated
NDC Package 67046-0363-3

11-digit billing NDC: 67046036303
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Olanzapine tablets is oral olanzapine is indicated for the treatment of schizophrenia. This formulation utilizes a tablet, film coated delivery system. Marketed by Coupler Llc, this product is identified by NDC 67046-0363 and is authorized under FDA application ANDA076255.

Identification & Billing

NDC Package Code
67046-0363-3
Package Description
30 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
67046-0363
11-Digit Billing Format
67046036303
RxNorm Crosswalk

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.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OLANZAPINE 7.5 mg/1
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
Usage Information
Oral olanzapine is indicated for the treatment of schizophrenia. Efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. In adolescent patients with schizophrenia (ages 13 to 17), efficacy was established in one 6-week trial  [see Clinical Studies ( 14.1)].    When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. Clinicians should consider the potential long-term risks  when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see   Warnings and Precautions ( 5.5)]. 

Regulatory & Marketing

Labeler Name
Coupler Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA076255
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-10-2026
Listing Expiration
12-31-2027
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 67046-0363-3 identifies a specific commercial package of 30 tablet, film coated in 1 blister pack of Olanzapine, a human prescription drug labeled by Coupler Llc. This tablet, film coated is formulated for oral 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 Coupler Llc on June 10, 2026. The current certification is valid through December 31, 2027.

How is this Coupler Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67046036303. 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)
67046-0363-3
11-Digit CMS (5-4-2)
67046-0363-03

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