Olanzapine And Fluoxetine Capsule
NDC Package 42291-655-30

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

Package Information

Olanzapine And Fluoxetine capsules is pimozide [ see Warnings and Precautions ( 5.19) and Drug Interactions ( 7.7, 7.8) ] Thioridazine [ see Warnings and Precautions ( 5.19) and Drug Interactions ( 7.7, 7.8) ] Pimozide and thioridazine prolong the QT interval. This formulation utilizes a capsule delivery system. Marketed by Avkare, this product is identified by NDC 42291-655 and is authorized under FDA application ANDA077528.

Identification & Billing

NDC Package Code
42291-655-30
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
42291-655
11-Digit Billing Format
42291065530
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk
  • RxCUI: 403969 - OLANZapine 6 MG / FLUoxetine HCl 25 MG Oral Capsule
  • RxCUI: 403969 - fluoxetine 25 MG / olanzapine 6 MG Oral Capsule
  • RxCUI: 403969 - fluoxetine 25 MG (as fluoxetine hydrochloride) / olanzapine 6 MG Oral Capsule
  • RxCUI: 403970 - OLANZapine 12 MG / FLUoxetine HCl 25 MG Oral Capsule
  • RxCUI: 403970 - fluoxetine 25 MG / olanzapine 12 MG Oral Capsule

Clinical Specifications

Proprietary Name
Olanzapine And Fluoxetine
Non-Proprietary Name
Olanzapine And Fluoxetine
Substance Name
Fluoxetine Hydrochloride; Olanzapine
Dosage Form
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Pimozide [ see Warnings and Precautions ( 5.19) and Drug Interactions ( 7.7, 7.8) ] Thioridazine [ see Warnings and Precautions ( 5.19) and Drug Interactions ( 7.7, 7.8) ] Pimozide and thioridazine prolong the QT interval. Olanzapine and fluoxetine capsules can increase the levels of pimozide and thioridazine through inhibition of CYP2D6. Olanzapine and fluoxetine capsules can also prolong the QT interval.

Regulatory & Marketing

Labeler Name
Avkare
Product Type
Human Prescription Drug
FDA Application #
ANDA077528
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-21-2014
Listing Expiration
12-31-2026
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 42291-655-30 identifies a specific commercial package of 30 capsule in 1 bottle of Olanzapine And Fluoxetine, a human prescription drug labeled by Avkare. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This capsule is formulated for oral use and contains fluoxetine hydrochloride; 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 Avkare on January 21, 2014. The current certification is valid through December 31, 2026.

How is this Avkare product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42291065530. 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)
42291-655-30
11-Digit CMS (5-4-2)
42291-0655-30

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