Fluvoxamine Maleate Extended-release Capsule, Extended Release
NDC Package 70710-1847-3

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Fluvoxamine Maleate Extended-release capsules is fluvoxamine is used to treat obsessive-compulsive disorder (OCD). This formulation utilizes a capsule, extended release delivery system. Marketed by Zydus Pharmaceuticals Usa Inc., this product is identified by NDC 70710-1847 and is authorized under FDA application ANDA220447.

Identification & Billing

NDC Package Code
70710-1847-3
Package Description
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE
Product Code
70710-1847
11-Digit Billing Format
70710184703

Clinical Specifications

Proprietary Name
Fluvoxamine Maleate Extended-release
Non-Proprietary Name
Fluvoxamine Maleate Extended-release
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)
FLUVOXAMINE MALEATE 100 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
Zydus Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA220447
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-04-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70710-1847-3 identifies a specific commercial package of 30 capsule, extended release in 1 bottle of Fluvoxamine Maleate Extended-release, a human prescription drug labeled by Zydus Pharmaceuticals Usa 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 Zydus Pharmaceuticals Usa Inc. on August 04, 2026. The current certification is valid through December 31, 2027.

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 Zydus Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70710184703. 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 (5-4-1)
70710-1847-3
11-Digit CMS (5-4-2)
70710-1847-03

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