Sildenafil
NDC Package 50436-0033-2

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 inactivated by the FDA.

Sildenafil is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Marketed by Unit Dose Services, this product is identified by NDC 50436-0033 and is authorized under FDA application NDA021845.

Identification & Billing

NDC Package Code
50436-0033-2
Package Description
1620 POUCH in 1 CASE / 2 TABLET, FILM COATED in 1 POUCH
Product Code
50436-0033
11-Digit Billing Format
50436003302
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sildenafil
Dosage Form
-
Usage Information
Sildenafil is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when sildenafil was added to background epoprostenol therapy [see Clinical Studies (14)].Studies establishing effectiveness were short-term (12 to 16 weeks), included predominately patients with New York Heart Association (NYHA) Functional Class II–III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).

Regulatory & Marketing

Labeler Name
Unit Dose Services
FDA Application #
NDA021845
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
09-27-2012
Listing Expiration
12-31-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (50436-0033). Click a package code to view its specific billing and regulatory data.

50436-0033-1
1890 POUCH in 1 CASE / 1 TABLET, FILM COATED in 1 POUCH
50436-0033-3
1620 POUCH in 1 CASE / 3 TABLET, FILM COATED in 1 POUCH
50436-0033-4
1350 POUCH in 1 CASE / 4 TABLET, FILM COATED in 1 POUCH
50436-0033-5
1350 POUCH in 1 CASE / 5 TABLET, FILM COATED in 1 POUCH

* 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 50436-0033-2 identifies a specific commercial package of 1620 pouch in 1 case / 2 tablet, film coated in 1 pouch of Sildenafil, labeled by Unit Dose Services. 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 Unit Dose Services on September 27, 2012. The current certification is valid through December 31, 2022.

How is this Unit Dose Services product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50436003302. 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)
50436-0033-2
11-Digit CMS (5-4-2)
50436-0033-02

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