Haloperidol Decanoate
NDC Package 53150-415-10

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Haloperidol Decanoate is used for long-term treatment of a certain mental/mood disorder (schizophrenia). Marketed by Amneal-agila, Llc, this product is identified by NDC 53150-415 and is authorized under FDA application ANDA075440.

Identification & Billing

NDC Package Code
53150-415-10
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE (53150-415-01)
Product Code
53150-415
11-Digit Billing Format
53150041510
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Haloperidol Decanoate
Dosage Form
-
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
Amneal-agila, Llc
FDA Application #
ANDA075440
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-23-2013
End Marketing Date
12-31-2017
Listing Expiration
12-31-2017
Exclude Flag
D
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 53150-415-10 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 1 ml in 1 vial, single-dose (53150-415-01) of Haloperidol Decanoate, labeled by Amneal-agila, Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Amneal-agila, Llc on April 23, 2013. The current certification is valid through December 31, 2017.

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 Amneal-agila, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53150041510. 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)
53150-415-10
11-Digit CMS (5-4-2)
53150-0415-10

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