Sildenafil Powder, For Suspension
NDC Package 60219-2651-1

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

Package Information

Sildenafil powders is adultsSildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)].Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) oral suspension. This formulation utilizes a powder, for suspension delivery system. Marketed by Amneal Pharmaceuticals Ny Llc, this product is identified by NDC 60219-2651 and is authorized under FDA application ANDA211092.

Identification & Billing

NDC Package Code
60219-2651-1
Package Description
1 BOTTLE, GLASS in 1 CARTON / 112 mL in 1 BOTTLE, GLASS
Product Code
60219-2651
11-Digit Billing Format
60219265101
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
Non-Proprietary Name
Sildenafil
Substance Name
Sildenafil
Dosage Form
Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SILDENAFIL 10 mg/mL
Pharmacologic Class
Usage Information
AdultsSildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)].Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) oral suspension. However, due to Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with that information.

Regulatory & Marketing

Labeler Name
Amneal Pharmaceuticals Ny Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA211092
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-02-2024
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 60219-2651-1 identifies a specific commercial package of 1 bottle, glass in 1 carton / 112 ml in 1 bottle, glass of Sildenafil, a human prescription drug labeled by Amneal Pharmaceuticals Ny Llc. This powder, for suspension is formulated for oral use and contains sildenafil 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 Amneal Pharmaceuticals Ny Llc on March 02, 2024. The current certification is valid through December 31, 2026.

How is this Amneal Pharmaceuticals Ny Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 60219265101. 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 (5-4-1)
60219-2651-1
11-Digit CMS (5-4-2)
60219-2651-01

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