Alprostadil Injection, Solution, Concentrate
NDC Package 71288-206-02

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

Package Information

Alprostadil injection is a medication used to treat male sexual function problems (erectile dysfunction). This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Meitheal Pharmaceuticals Inc., this product is identified by NDC 71288-206 and is authorized under FDA application ANDA075196.

Identification & Billing

NDC Package Code
71288-206-02
Package Description
10 VIAL, SINGLE-USE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-USE (71288-206-01)
Product Code
71288-206
11-Digit Billing Format
71288020602
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Alprostadil
Non-Proprietary Name
Alprostadil
Substance Name
Alprostadil
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route
Intravascular - Administration within a vessel or vessels.
Active Ingredient(s)
ALPROSTADIL 500 ug/mL
Pharmacologic Class
Usage Information
This medication is used to treat male sexual function problems (erectile dysfunction). It works by helping the blood flow into the penis to achieve and maintain an erection. This medication is not for use in women or children. This medication is not recommended for use in men with penile implants.

Regulatory & Marketing

Labeler Name
Meitheal Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA075196
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-15-2024
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J0270
Source: PDAC
INJECTION, ALPROSTADIL, 1.25 MCG (CODE MAY BE USED FOR MEDICARE WHEN DRUG ADMINISTERED UNDER THE DIRECT SUPERVISION OF A PHYSICIAN, NOT FOR USE WHEN DRUG IS SELF ADMINISTERED)
HCPCS Dosage 1.25 MCG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 71288-206-02 identifies a specific commercial package of 10 vial, single-use in 1 carton / 1 ml in 1 vial, single-use (71288-206-01) of Alprostadil, a human prescription drug labeled by Meitheal Pharmaceuticals Inc.. This injection, solution, concentrate is formulated for intravascular use and contains alprostadil 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 Meitheal Pharmaceuticals Inc. on September 15, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat male sexual function problems (erectile dysfunction). It works by helping the blood flow into the penis to achieve and maintain an erection. This medication is not for use in women or children. This medication is not recommended for use in men with penile implants.

How is this Meitheal Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71288020602. 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 (5-3-2)
71288-206-02
11-Digit CMS (5-4-2)
71288-0206-02

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