Addyi Tablet, Film Coated
NDC Package 58604-214-30

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

Addyi (flibanserin) tablets is aDDYI® (flibanserin) tablets are indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to: •A co-existing medical or psychiatric condition,•Problems within the relationship, or•The effects of a medication or other drug substance.Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. This formulation utilizes a tablet, film coated delivery system. Marketed by Sprout Pharmaceuticals, Inc., this product is identified by NDC 58604-214 and is authorized under FDA application NDA022526.

Identification & Billing

NDC Package Code
58604-214-30
Package Description
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
Product Code
58604-214
11-Digit Billing Format
58604021430
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Addyi
Non-Proprietary Name
Flibanserin
Substance Name
Flibanserin
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)
FLIBANSERIN 100 mg/1
Pharmacologic Class
P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
Usage Information
ADDYI® (flibanserin) tablets are indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to: •A co-existing medical or psychiatric condition,•Problems within the relationship, or•The effects of a medication or other drug substance.Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner. Limitations of Use•ADDYI is not indicated for the treatment of HSDD in postmenopausal women or in men.•ADDYI is not indicated to enhance sexual performance.

Regulatory & Marketing

Labeler Name
Sprout Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA022526
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-18-2015
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (58604-214). Click a package code to view its specific billing and regulatory data.

58604-214-03
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED 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 58604-214-30 identifies a specific commercial package of 1 bottle in 1 carton / 30 tablet, film coated in 1 bottle of Addyi, a human prescription drug labeled by Sprout Pharmaceuticals, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This tablet, film coated is formulated for oral use and contains flibanserin 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 Sprout Pharmaceuticals, Inc. on August 18, 2015. The current certification is valid through December 31, 2026.

How is this Sprout Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58604021430. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (5-3-2)
58604-214-30
11-Digit CMS (5-4-2)
58604-0214-30

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