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  5. NDC Package Code: 58604-214-03 Addyi

NDC Package 58604-214-03 Addyi

Flibanserin Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
58604-214-03
Package Description:
1 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE
Product Code:
58604-214
Proprietary Name:
Addyi
Non-Proprietary Name:
Flibanserin
Substance Name:
Flibanserin
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.
11-Digit NDC Billing Format:
58604021403
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Sprout Pharmaceuticals, Inc.
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
FLIBANSERIN 100 mg/1
Pharmacologic Class(es):
P-Glycoprotein Inhibitors - [MoA] (Mechanism of Action)
Sample Package:
No
FDA Application Number:
NDA022526
Marketing Category:
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date:
08-18-2015
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
58604-214-301 BOTTLE in 1 CARTON / 30 TABLET, FILM COATED in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 58604-214-03?

The NDC Packaged Code 58604-214-03 is assigned to a 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.. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 58604-214 included in the NDC Directory?

Yes, Addyi with product code 58604-214 is active and included in the NDC Directory. The product was first marketed by Sprout Pharmaceuticals, Inc. on August 18, 2015 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 58604-214-03?

The 11-digit format is 58604021403. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-258604-214-035-4-258604-0214-03