Sarafem
NDC Package 0430-0435-95

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 discontinued by the firm.

Sarafem is fluoxetine is used to treat depression, panic attacks, obsessive compulsive disorder, a certain eating disorder (bulimia), and a severe form of premenstrual syndrome (premenstrual dysphoric disorder). Marketed by Warner Chilcott, Inc., this product is identified by NDC 0430-0435 and is authorized under FDA application NDA018936.

Identification & Billing

NDC Package Code
0430-0435-95
Package Description
1 BLISTER PACK in 1 CARTON / 14 CAPSULE in 1 BLISTER PACK
Product Code
0430-0435
11-Digit Billing Format
00430043595

Clinical Specifications

Proprietary Name
Sarafem
Dosage Form
-
Usage Information
Fluoxetine is used to treat depression, panic attacks, obsessive compulsive disorder, a certain eating disorder (bulimia), and a severe form of premenstrual syndrome (premenstrual dysphoric disorder). This medication may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. It may decrease fear, anxiety, unwanted thoughts, and the number of panic attacks. It may also reduce the urge to perform repeated tasks (compulsions such as hand-washing, counting, and checking) that interfere with daily living. Fluoxetine may lessen premenstrual symptoms such as irritability, increased appetite, and depression. It may decrease binging and purging behaviors in bulimia.

Regulatory & Marketing

Labeler Name
Warner Chilcott, Inc.
FDA Application #
NDA018936
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-01-2006
End Marketing Date
06-30-2009
Listing Expiration
06-30-2009
Exclude Flag
D
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 (0430-0435). Click a package code to view its specific billing and regulatory data.

0430-0435-14
4 BLISTER PACK in 1 CARTON / 7 CAPSULE in 1 BLISTER PACK

* 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 0430-0435-95 identifies a specific commercial package of 1 blister pack in 1 carton / 14 capsule in 1 blister pack of Sarafem, labeled by Warner Chilcott, Inc.. 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 Warner Chilcott, Inc. on May 01, 2006. The current certification is valid through June 30, 2009.

What are the primary indications for this medication?

Fluoxetine is used to treat depression, panic attacks, obsessive compulsive disorder, a certain eating disorder (bulimia), and a severe form of premenstrual syndrome (premenstrual dysphoric disorder). This medication may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. It may decrease fear, anxiety, unwanted thoughts, and the number of panic attacks. It may also reduce the urge to perform repeated tasks (compulsions such as hand-washing, counting, and checking) that interfere with daily living. Fluoxetine may lessen premenstrual symptoms such as irritability, increased appetite, and depression. It may decrease binging and purging behaviors in bulimia.

How is this Warner Chilcott, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00430043595. 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)
0430-0435-95
11-Digit CMS (5-4-2)
00430-0435-95

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