Haloperidol Decanoate Injection
NDC Package 68083-137-10
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 Gland Pharma Limited, this product is identified by NDC 68083-137 and is authorized under FDA application ANDA205241.
Identification & Billing
- RxCUI: 1719803 - haloperidol decanoate 100 MG in 1 ML Injection
- RxCUI: 1719803 - 1 ML haloperidol decanoate 100 MG/ML Injection
- RxCUI: 1719803 - haloperidol decanoate 100 MG per 1 ML Injection
- RxCUI: 1719862 - haloperidol decanoate 50 MG in 1 ML Injection
- RxCUI: 1719862 - 1 ML haloperidol decanoate 50 MG/ML Injection
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 68083 - Gland Pharma Limited
- 68083-137 - Haloperidol Decanoate
- 68083-137-10 - 10 VIAL in 1 CARTON / 1 mL in 1 VIAL
- 68083-137 - Haloperidol Decanoate
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 (68083-137). Click a package code to view its specific billing and regulatory data.
* 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 68083-137-10 identifies a specific commercial package of 10 vial in 1 carton / 1 ml in 1 vial of Haloperidol Decanoate, a human prescription drug labeled by Gland Pharma Limited. 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 Gland Pharma Limited on January 16, 2017. The current certification is valid through December 31, 2026.
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 Gland Pharma Limited product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083013710. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
