Fluvoxamine Maleate Capsule, Extended Release
NDC Package 0228-2849-00

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

Fluvoxamine Maleate capsules is fluvoxamine is used to treat obsessive-compulsive disorder (OCD). This formulation utilizes a capsule, extended release delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0228-2849 and is authorized under FDA application ANDA091482.

Identification & Billing

NDC Package Code
0228-2849-00
Package Description
8759 CAPSULE, EXTENDED RELEASE in 1 CONTAINER
Product Code
0228-2849
11-Digit Billing Format
00228284900
RxNorm Crosswalk
  • RxCUI: 903873 - fluvoxaMINE maleate 100 MG 24HR Extended Release Oral Capsule
  • RxCUI: 903873 - 24 HR fluvoxamine maleate 100 MG Extended Release Oral Capsule
  • RxCUI: 903873 - fluvoxamine maleate 100 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 903879 - fluvoxaMINE maleate 150 MG 24HR Extended Release Oral Capsule
  • RxCUI: 903879 - 24 HR fluvoxamine maleate 150 MG Extended Release Oral Capsule

Clinical Specifications

Proprietary Name
Fluvoxamine Maleate
Non-Proprietary Name
Fluvoxamine Maleate
Substance Name
Fluvoxamine Maleate
Dosage Form
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Fluvoxamine is used to treat obsessive-compulsive disorder (OCD). It helps decrease persistent/unwanted thoughts (obsessions) and urges to perform repeated tasks (compulsions such as hand-washing, counting, checking) that interfere with daily living. Fluvoxamine is known as a selective serotonin reuptake inhibitor (SSRI). This medication works by helping to restore the balance of a certain natural substance (serotonin) in the brain.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA091482
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-05-2014
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
N/A

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 (0228-2849). Click a package code to view its specific billing and regulatory data.

0228-2849-03
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

* 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 0228-2849-00 identifies a specific commercial package of 8759 capsule, extended release in 1 container of Fluvoxamine Maleate, a human prescription drug labeled by Actavis Pharma, Inc.. This capsule, extended release is formulated for oral use and contains fluvoxamine maleate 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 Actavis Pharma, Inc. on August 05, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Fluvoxamine is used to treat obsessive-compulsive disorder (OCD). It helps decrease persistent/unwanted thoughts (obsessions) and urges to perform repeated tasks (compulsions such as hand-washing, counting, checking) that interfere with daily living. Fluvoxamine is known as a selective serotonin reuptake inhibitor (SSRI). This medication works by helping to restore the balance of a certain natural substance (serotonin) in the brain.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00228284900. 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 (4-4-2)
0228-2849-00
11-Digit CMS (5-4-2)
00228-2849-00

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