Sildenafil
NDC Package 53002-3719-3

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 EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Sildenafil is adults Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies ( 14)]. Marketed by Rpk Pharmaceuticals, Inc., this product is identified by NDC 53002-3719 and is authorized under FDA application ANDA203623.

Identification & Billing

NDC Package Code
53002-3719-3
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
53002-3719
11-Digit Billing Format
53002371903
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sildenafil
Dosage Form
-
Usage Information
Adults Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies ( 14)] . Pediatric Patients (1 to 17 Years old) Sildenafil tablets are indicated in pediatric patients 1 to 17 years old for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to improve exercise ability and, in pediatric patients too young to perform standardized exercise testing, pulmonary hemodynamics thought to underly improvements in exercise [see Clinical Studies ( 14)] . 

Regulatory & Marketing

Labeler Name
Rpk Pharmaceuticals, Inc.
FDA Application #
ANDA203623
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-26-2014
Listing Expiration
12-31-2024
Exclude Flag
I
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 53002-3719-3 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Sildenafil, labeled by Rpk Pharmaceuticals, 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 Rpk Pharmaceuticals, Inc. on November 26, 2014. The current certification is valid through December 31, 2024.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53002371903. 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)
53002-3719-3
11-Digit CMS (5-4-2)
53002-3719-03

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