Sildenafil For Oral Suspension
NDC Package 72205-035-76

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 For Oral Suspension is  is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Marketed by Novadoz Pharmaceuticals Llc, this product is identified by NDC 72205-035 and is authorized under FDA application ANDA213041.

Identification & Billing

NDC Package Code
72205-035-76
Package Description
1 BOTTLE in 1 CARTON / 112 mL in 1 BOTTLE
Product Code
72205-035
11-Digit Billing Format
72205003576
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sildenafil For Oral Suspension
Dosage Form
-
Usage Information
Sildenafil for Oral Suspension 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 for Oral Suspension was added to background epoprostenol therapy [see Clinical Studies (14)].Studies establishing effectiveness were short-term (12 to 16 weeks), and 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
Novadoz Pharmaceuticals Llc
FDA Application #
ANDA213041
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-01-2020
Listing Expiration
12-31-2021
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 72205-035-76 identifies a specific commercial package of 1 bottle in 1 carton / 112 ml in 1 bottle of Sildenafil For Oral Suspension, labeled by Novadoz Pharmaceuticals Llc. 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 Novadoz Pharmaceuticals Llc on September 01, 2020. The current certification is valid through December 31, 2021.

How is this Novadoz Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72205003576. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
72205-035-76
11-Digit CMS (5-4-2)
72205-0035-76

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