Sildenafil Tablet
NDC Package 76282-643-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Sildenafil tablets is sildenafil is used to treat high blood pressure in the lungs (pulmonary hypertension). This formulation utilizes a tablet delivery system. Marketed by Exelan Pharmaceuticals, Inc., this product is identified by NDC 76282-643 and is authorized under FDA application ANDA207178.

Identification & Billing

NDC Package Code
76282-643-30
Package Description
30 TABLET in 1 BOTTLE
Product Code
76282-643
11-Digit Billing Format
76282064330
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sildenafil
Non-Proprietary Name
Sildenafil
Substance Name
Sildenafil Citrate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SILDENAFIL CITRATE 25 mg/1
Pharmacologic Class
Usage Information
Sildenafil is used to treat high blood pressure in the lungs (pulmonary hypertension). It works by relaxing and widening the blood vessels in your lungs which allows the blood to flow more easily. Decreasing high blood pressure in the lungs allows your heart and lungs to work better and improves your ability to exercise. This medication is not recommended for use in children. Discuss the risks and benefits of this medication with the doctor.

Regulatory & Marketing

Labeler Name
Exelan Pharmaceuticals, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA207178
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-2022
Listing Expiration
12-31-2026
Exclude Flag
N
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 76282-643-30 identifies a specific commercial package of 30 tablet in 1 bottle of Sildenafil, a human prescription drug labeled by Exelan Pharmaceuticals, Inc.. This tablet is formulated for oral use and contains sildenafil citrate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Exelan Pharmaceuticals, Inc. on July 01, 2022. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Sildenafil is used to treat high blood pressure in the lungs (pulmonary hypertension). It works by relaxing and widening the blood vessels in your lungs which allows the blood to flow more easily. Decreasing high blood pressure in the lungs allows your heart and lungs to work better and improves your ability to exercise. This medication is not recommended for use in children. Discuss the risks and benefits of this medication with the doctor.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76282064330. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
76282-643-30
11-Digit CMS (5-4-2)
76282-0643-30

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