Zyprexa Tablet, Orally Disintegrating
NDC Package 61269-652-35

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

Package Information

Zyprexa (olanzapine) tablets is olanzapine is used to treat certain mental/mood conditions (such as schizophrenia, bipolar disorder). This formulation utilizes a tablet, orally disintegrating delivery system. Marketed by H2-pharma Llc, this product is identified by NDC 61269-652 and is authorized under FDA application NDA021086.

Identification & Billing

NDC Package Code
61269-652-35
Package Description
30 DOSE PACK in 1 CARTON / 1 BLISTER PACK in 1 DOSE PACK (61269-652-01) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code
61269-652
11-Digit Billing Format
61269065235
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
Zyprexa Zydis
Non-Proprietary Name
Olanzapine
Substance Name
Olanzapine
Dosage Form
Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
OLANZAPINE 15 mg/1
Pharmacologic Class
Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
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
H2-pharma Llc
Product Type
Human Prescription Drug
FDA Application #
NDA021086
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-01-2001
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 61269-652-35 identifies a specific commercial package of 30 dose pack in 1 carton / 1 blister pack in 1 dose pack (61269-652-01) / 1 tablet, orally disintegrating in 1 blister pack of Zyprexa Zydis, a human prescription drug labeled by H2-pharma Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This tablet, orally disintegrating 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 H2-pharma Llc on September 01, 2001. 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 H2-pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61269065235. 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)
61269-652-35
11-Digit CMS (5-4-2)
61269-0652-35

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