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  5. NDC Package Code: 53002-4719-3 Sildenafil

NDC Package 53002-4719-3 Sildenafil

View Billable Units, 11-Digit Format, RxNorm

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.

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:
53002-4719-3
Package Description:
30 TABLET in 1 BOTTLE
Product Code:
53002-4719
Proprietary Name:
Sildenafil
Usage Information:
AdultsSildenafil tablets, USP 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)]. Treatment of PAH in Pediatric Patients (Ages 1-17) information is approved for Viatris Specialty LLC’s Revatio (Sildenafil) tablets. However, due to Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with this information.
11-Digit NDC Billing Format:
53002471903
NDC to RxNorm Crosswalk:
Labeler Name:
Rpk Pharmaceuticals, Inc.
Sample Package:
No
FDA Application Number:
ANDA210394
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
05-04-2018
Listing Expiration Date:
12-31-2024
Exclude Flag:
I
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.

Frequently Asked Questions

What is NDC 53002-4719-3?

The NDC Packaged Code 53002-4719-3 is assigned to a package of 30 tablet in 1 bottle of Sildenafil, labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is and is administered via form.

Is NDC 53002-4719 included in the NDC Directory?

No, Sildenafil with product code 53002-4719 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Rpk Pharmaceuticals, Inc. on May 04, 2018 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 53002-4719-3?

The 11-digit format is 53002471903. 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 5-4-1 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
5-4-153002-4719-35-4-253002-4719-03