Sildenafil Citrate
NDC Package 83008-038-50

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 discontinued by the firm.

Sildenafil Citrate is sildenafil is used to treat high blood pressure in the lungs (pulmonary hypertension). Marketed by Quality Care Products, Llc, this product is identified by NDC 83008-038 and is authorized under FDA application ANDA091479.

Identification & Billing

NDC Package Code
83008-038-50
Package Description
50 TABLET in 1 BOTTLE
Product Code
83008-038
11-Digit Billing Format
83008003850
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
50 EA

Clinical Specifications

Proprietary Name
Sildenafil Citrate
Dosage Form
-
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
Quality Care Products, Llc
FDA Application #
ANDA091479
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-03-2023
End Marketing Date
12-31-2025
Listing Expiration
12-31-2025
Exclude Flag
D
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 83008-038-50 identifies a specific commercial package of 50 tablet in 1 bottle of Sildenafil Citrate, labeled by Quality Care Products, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 50 billable units per package. 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 Quality Care Products, Llc on August 03, 2023. The current certification is valid through December 31, 2025.

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 Quality Care Products, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83008003850. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 50 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)
83008-038-50
11-Digit CMS (5-4-2)
83008-0038-50

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