Olanzapine And Fluoxetine Capsule
NDC Package 49884-252-11

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 (olanzapine and fuoxetine) capsules is olanzapine and Fluoxetine is indicated for the treatment of:Acute depressive episodes in Bipolar I Disorder[see Clinical Studies (14.1)]. This formulation utilizes a capsule delivery system. Marketed by Par Health Usa, Llc, this product is identified by NDC 49884-252 and is authorized under FDA application ANDA077742.

Identification & Billing

NDC Package Code
49884-252-11
Package Description
30 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
49884-252
11-Digit Billing Format
49884025211
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 Fuoxetine
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
Olanzapine and Fluoxetine is indicated for the treatment of:Acute depressive episodes in Bipolar I Disorder[see Clinical Studies (14.1)]. Treatment resistant depression (Major Depressive Disorder in patient who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) [see Clinical Studies (14.2)].

Regulatory & Marketing

Labeler Name
Par Health Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA077742
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-26-2012
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 49884-252-11 identifies a specific commercial package of 30 capsule in 1 bottle, plastic of Olanzapine And Fluoxetine, a human prescription drug labeled by Par Health Usa, Llc. 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 Par Health Usa, Llc on November 26, 2012. The current certification is valid through December 31, 2027.

How is this Par Health Usa, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49884025211. 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)
49884-252-11
11-Digit CMS (5-4-2)
49884-0252-11

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