Fluoxetine
NDC Package 42549-599-30

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Fluoxetine is when using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for olanzapine and fluoxetine hydrochloride capsules. The use of fluoxetine is contraindicated with the following:Monoamine Oxidase Inhibitors  [see Drug Interactions (7.1)] Pimozide [see Drug Interactions (7.9)] Thioridazine [see Drug Interactions (7.9)]. Marketed by Stat Rx Usa Llc, this product is identified by NDC 42549-599 and is authorized under FDA application ANDA076001.

Identification & Billing

NDC Package Code
42549-599-30
Package Description
30 CAPSULE in 1 BOTTLE
Product Code
42549-599
11-Digit Billing Format
42549059930
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
Fluoxetine
Dosage Form
-
Usage Information
When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for olanzapine and fluoxetine hydrochloride capsules. The use of fluoxetine is contraindicated with the following:Monoamine Oxidase Inhibitors  [see Drug Interactions (7.1)] Pimozide [see Drug Interactions (7.9)] Thioridazine [see Drug Interactions (7.9)]

Regulatory & Marketing

Labeler Name
Stat Rx Usa Llc
FDA Application #
ANDA076001
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-20-2012
Listing Expiration
12-31-2017
Exclude Flag
I
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 42549-599-30 identifies a specific commercial package of 30 capsule in 1 bottle of Fluoxetine, labeled by Stat Rx Usa Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Stat Rx Usa Llc on March 20, 2012. The current certification is valid through December 31, 2017.

How is this Stat Rx Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42549059930. 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)
42549-599-30
11-Digit CMS (5-4-2)
42549-0599-30

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