Haloperidol Decanoate Injection
NDC Package 72485-521-10

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

Package Information

Haloperidol Decanoate injection is haloperidol decanoate is used for long-term treatment of a certain mental/mood disorder (schizophrenia). This formulation utilizes a injection delivery system. Marketed by Armas Pharmaceuticals Inc., this product is identified by NDC 72485-521 and is authorized under FDA application ANDA219168.

Identification & Billing

NDC Package Code
72485-521-10
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE (72485-521-01)
Product Code
72485-521
11-Digit Billing Format
72485052110
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Haloperidol Decanoate
Non-Proprietary Name
Haloperidol Decanoate
Substance Name
Haloperidol Decanoate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
HALOPERIDOL DECANOATE 100 mg/mL
Pharmacologic Class
Typical Antipsychotic - [EPC] (Established Pharmacologic Class)
Usage Information
Haloperidol decanoate is used for long-term treatment of a certain mental/mood disorder (schizophrenia). It may be used in people who have trouble remembering to take medication every day. This medicine helps you to think more clearly, feel less nervous, and take part in everyday life. It can also prevent suicide in people who are likely to harm themselves. It also reduces aggression and the desire to hurt others. It can decrease negative thoughts and hallucinations. Haloperidol decanoate is a long-acting form of psychiatric medication (antipsychotic-type) that works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain.

Regulatory & Marketing

Labeler Name
Armas Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA219168
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-15-2026
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 72485-521-10 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 1 ml in 1 vial, single-dose (72485-521-01) of Haloperidol Decanoate, a human prescription drug labeled by Armas Pharmaceuticals Inc.. This injection is formulated for intramuscular use and contains haloperidol decanoate 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 Armas Pharmaceuticals Inc. on May 15, 2026. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Haloperidol decanoate is used for long-term treatment of a certain mental/mood disorder (schizophrenia). It may be used in people who have trouble remembering to take medication every day. This medicine helps you to think more clearly, feel less nervous, and take part in everyday life. It can also prevent suicide in people who are likely to harm themselves. It also reduces aggression and the desire to hurt others. It can decrease negative thoughts and hallucinations. Haloperidol decanoate is a long-acting form of psychiatric medication (antipsychotic-type) that works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72485052110. 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)
72485-521-10
11-Digit CMS (5-4-2)
72485-0521-10

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