Fluvoxamine Maleate Tablet, Film Coated
NDC Package 0832-1671-11

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Fluvoxamine Maleate tablets is fluvoxamine is used to treat obsessive-compulsive disorder (OCD). This formulation utilizes a tablet, film coated delivery system. Marketed by Upsher-smith Laboratories, Llc, this product is identified by NDC 0832-1671 and is authorized under FDA application ANDA075888.

Identification & Billing

NDC Package Code
0832-1671-11
Package Description
100 TABLET, FILM COATED in 1 BOTTLE
Product Code
0832-1671
11-Digit Billing Format
00832167111
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fluvoxamine Maleate
Non-Proprietary Name
Fluvoxamine Maleate
Substance Name
Fluvoxamine Maleate
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
FLUVOXAMINE MALEATE 50 mg/1
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
Upsher-smith Laboratories, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA075888
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-29-2000
End Marketing Date
06-30-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0832-1671-11 identifies a specific commercial package of 100 tablet, film coated in 1 bottle of Fluvoxamine Maleate, a human prescription drug labeled by Upsher-smith Laboratories, Llc. This tablet, film coated 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 Upsher-smith Laboratories, Llc on November 29, 2000.

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 Upsher-smith Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00832167111. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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 (4-4-2)
0832-1671-11
11-Digit CMS (5-4-2)
00832-1671-11

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