Apomorphine Hydrocloride Injection
NDC Package 52817-720-05

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

Package Information

Apomorphine Hydrocloride (apomorphine hydrochloride) injection is apomorphine hydrochloride injection is indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) in patients with advanced Parkinson's disease. This formulation utilizes a injection delivery system. Marketed by Trupharma, Llc, this product is identified by NDC 52817-720 and is authorized under FDA application ANDA212025.

Identification & Billing

NDC Package Code
52817-720-05
Package Description
5 CARTRIDGE in 1 CARTON / 3 mL in 1 CARTRIDGE (52817-720-01)
Product Code
52817-720
11-Digit Billing Format
52817072005
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Apomorphine Hydrocloride
Non-Proprietary Name
Apomorphine Hydrochloride
Substance Name
Apomorphine Hydrochloride
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
APOMORPHINE HYDROCHLORIDE 30 mg/3mL
Pharmacologic Class
Usage Information
Apomorphine hydrochloride injection is indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) in patients with advanced Parkinson's disease. Apomorphine hydrocloride inejction has been studied as an adjunct to other medications [see Clinical Studies (14)].

Regulatory & Marketing

Labeler Name
Trupharma, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA212025
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-24-2022
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 52817-720-05 identifies a specific commercial package of 5 cartridge in 1 carton / 3 ml in 1 cartridge (52817-720-01) of Apomorphine Hydrocloride, a human prescription drug labeled by Trupharma, Llc. This injection is formulated for subcutaneous use and contains apomorphine hydrochloride 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 Trupharma, Llc on February 24, 2022. The current certification is valid through December 31, 2026.

How is this Trupharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52817072005. 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)
52817-720-05
11-Digit CMS (5-4-2)
52817-0720-05

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