Fluoxetine
NDC Package 29033-503-31

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 the use of fluoxetine is contraindicated with the following:Pimozide [see Warnings and Precautions (5.11) and Drug Interactions (7.7,7.8)] Thioridazine [see Warnings and Precautions (5.11) and Drug Interactions (7.7,7.8)] Pimozide and thioridazine prolong the QT interval. Marketed by Nostrum Laboratories Inc., this product is identified by NDC 29033-503 and is authorized under FDA application ANDA075292.

Identification & Billing

NDC Package Code
29033-503-31
Package Description
120 mL in 1 BOTTLE, PLASTIC
Product Code
29033-503
11-Digit Billing Format
29033050331
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
120 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fluoxetine
Dosage Form
-
Usage Information
The use of fluoxetine is contraindicated with the following:Pimozide [see Warnings and Precautions (5.11) and Drug Interactions (7.7,7.8)] Thioridazine [see Warnings and Precautions (5.11) and Drug Interactions (7.7,7.8)] Pimozide and thioridazine prolong the QT interval. Fluoxetine can increase the levels of pimozide and thioridazine through inhibition of CYP2D6. Fluoxetine can also prolong the QT interval.

Regulatory & Marketing

Labeler Name
Nostrum Laboratories Inc.
FDA Application #
ANDA075292
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-21-2023
Listing Expiration
12-31-2025
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 29033-503-31 identifies a specific commercial package of 120 ml in 1 bottle, plastic of Fluoxetine, labeled by Nostrum Laboratories Inc.. 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 Nostrum Laboratories Inc. on March 21, 2023. The current certification is valid through December 31, 2025.

How is this Nostrum Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 29033050331. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 120 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)
29033-503-31
11-Digit CMS (5-4-2)
29033-0503-31

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