Fluoxetine Hydrochloride Tablet, Coated
NDC Package 49884-335-82

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

Fluoxetine Hydrochloride tablets is when using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax. This formulation utilizes a tablet, coated delivery system. Marketed by Par Health Usa, Llc, this product is identified by NDC 49884-335 and is authorized under FDA application ANDA203836.

Identification & Billing

NDC Package Code
49884-335-82
Package Description
2000 TABLET, COATED in 1 BOTTLE, PLASTIC
Product Code
49884-335
11-Digit Billing Format
49884033582

Clinical Specifications

Proprietary Name
Fluoxetine Hydrochloride
Non-Proprietary Name
Fluoxetine Hydrochloride
Substance Name
Fluoxetine Hydrochloride
Dosage Form
Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FLUOXETINE HYDROCHLORIDE 10 mg/1
Pharmacologic Class
Usage Information
When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax.

Regulatory & Marketing

Labeler Name
Par Health Usa, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA203836
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-22-2016
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (49884-335). Click a package code to view its specific billing and regulatory data.

49884-335-01
100 TABLET, COATED in 1 BOTTLE, PLASTIC
49884-335-10
1000 TABLET, COATED in 1 BOTTLE, PLASTIC
49884-335-11
30 TABLET, COATED 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 49884-335-82 identifies a specific commercial package of 2000 tablet, coated in 1 bottle, plastic of Fluoxetine Hydrochloride, a human prescription drug labeled by Par Health Usa, Llc. This tablet, coated is formulated for oral use and contains fluoxetine hydrochloride 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 August 22, 2016. 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: 49884033582. 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)
49884-335-82
11-Digit CMS (5-4-2)
49884-0335-82

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