Sildenafil Citrate Powder, For Suspension
NDC Package 70710-1716-4

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 Citrate powders is sildenafil is used to treat high blood pressure in the lungs (pulmonary hypertension). This formulation utilizes a powder, for suspension delivery system. Marketed by Zydus Pharmaceuticals (usa) Inc., this product is identified by NDC 70710-1716 and is authorized under FDA application ANDA215708.

Identification & Billing

NDC Package Code
70710-1716-4
Package Description
1 BOTTLE, GLASS in 1 CARTON / 112 mL in 1 BOTTLE, GLASS
Product Code
70710-1716
11-Digit Billing Format
70710171604
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 Citrate
Non-Proprietary Name
Sildenafil Citrate
Substance Name
Sildenafil Citrate
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 CITRATE 10 mg/mL
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
Zydus Pharmaceuticals (usa) Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA215708
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-27-2022
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 (70710-1716). Click a package code to view its specific billing and regulatory data.

70710-1716-5
1 BOTTLE, PLASTIC in 1 CARTON / 112 mL in 1 BOTTLE, PLASTIC

* 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 70710-1716-4 identifies a specific commercial package of 1 bottle, glass in 1 carton / 112 ml in 1 bottle, glass of Sildenafil Citrate, a human prescription drug labeled by Zydus Pharmaceuticals (usa) Inc.. This powder, for suspension 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 Zydus Pharmaceuticals (usa) Inc. on October 27, 2022. 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 Zydus Pharmaceuticals (usa) Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70710171604. 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)
70710-1716-4
11-Digit CMS (5-4-2)
70710-1716-04

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