Sildenafil Citrate Tablet
NDC Package 53401-046-52

11-digit billing NDC: 53401004652
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Sildenafil Citrate tablets is sildenafil tablets are indicated for the treatment of erectile dysfunction. This formulation utilizes a tablet delivery system. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 53401-046 and is authorized under FDA application ANDA209302.

Identification & Billing

NDC Package Code
53401-046-52
Package Description
18 TABLET in 1 BOTTLE
Product Code
53401-046
11-Digit Billing Format
53401004652

Clinical Specifications

Proprietary Name
Sildenafil Citrate
Non-Proprietary Name
Sildenafil Citrate
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 100 mg/1
Pharmacologic Class
Usage Information
Sildenafil tablets are indicated for the treatment of erectile dysfunction.

Regulatory & Marketing

Labeler Name
Aphena Pharma Solutions - Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA209302
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-24-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 53401-046-52 identifies a specific commercial package of 18 tablet in 1 bottle of Sildenafil Citrate, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. 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 Aphena Pharma Solutions - Tennessee, Llc on February 24, 2026. The current certification is valid through December 31, 2027.

How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53401004652. 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)
53401-046-52
11-Digit CMS (5-4-2)
53401-0046-52

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