Fluoxetine
NDC Package 33261-045-28

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. 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 capsules and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax. Marketed by Aidarex Pharmaceuticals Llc, this product is identified by NDC 33261-045 and is authorized under FDA application ANDA078619.

Identification & Billing

NDC Package Code
33261-045-28
Package Description
28 CAPSULE in 1 BOTTLE, PLASTIC
Product Code
33261-045
11-Digit Billing Format
33261004528
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
28 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fluoxetine
Dosage Form
-
Usage Information
When using fluoxetine capsules and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax.

Regulatory & Marketing

Labeler Name
Aidarex Pharmaceuticals Llc
FDA Application #
ANDA078619
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-31-2008
Listing Expiration
12-31-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (33261-045). Click a package code to view its specific billing and regulatory data.

33261-045-30
30 CAPSULE in 1 BOTTLE, PLASTIC
33261-045-60
60 CAPSULE in 1 BOTTLE, PLASTIC
33261-045-90
90 CAPSULE in 1 BOTTLE, PLASTIC

* 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 33261-045-28 identifies a specific commercial package of 28 capsule in 1 bottle, plastic of Fluoxetine, labeled by Aidarex Pharmaceuticals Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 28 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 Aidarex Pharmaceuticals Llc on January 31, 2008. The current certification is valid through December 31, 2019.

How is this Aidarex Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 33261004528. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 28 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)
33261-045-28
11-Digit CMS (5-4-2)
33261-0045-28

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