Sildenafil Tablet, Film Coated
NDC Package 35561-252-10

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

Sildenafil tablets is sildenafil is used to treat high blood pressure in the lungs (pulmonary hypertension). This formulation utilizes a tablet, film coated delivery system. Marketed by Bostal Llc, this product is identified by NDC 35561-252 and is authorized under FDA application ANDA208494.

Identification & Billing

NDC Package Code
35561-252-10
Package Description
30 TABLET, FILM COATED in 1 BOTTLE
Product Code
35561-252
11-Digit Billing Format
35561025210
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sildenafil
Non-Proprietary Name
Sildenafil
Substance Name
Sildenafil Citrate
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SILDENAFIL CITRATE 50 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
Bostal Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA208494
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-22-2020
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (35561-252). Click a package code to view its specific billing and regulatory data.

35561-252-14
1000 TABLET, FILM COATED in 1 BOTTLE

* 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 35561-252-10 identifies a specific commercial package of 30 tablet, film coated in 1 bottle of Sildenafil, a human prescription drug labeled by Bostal Llc. This tablet, film coated 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 Bostal Llc on April 22, 2020. The current certification is valid through December 31, 2027.

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 Bostal Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35561025210. 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)
35561-252-10
11-Digit CMS (5-4-2)
35561-0252-10

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