Haloperidol Tablet
NDC Package 0378-0334-01

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Haloperidol tablets is haloperidol is used to treat certain mental/mood disorders (e.g., schizophrenia, schizoaffective disorders). This formulation utilizes a tablet delivery system. Marketed by Mylan Pharmaceuticals Inc., this product is identified by NDC 0378-0334 and is authorized under FDA application ANDA070278.

Identification & Billing

NDC Package Code
0378-0334-01
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
0378-0334
11-Digit Billing Format
00378033401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Haloperidol
Non-Proprietary Name
Haloperidol
Substance Name
Haloperidol
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
HALOPERIDOL 10 mg/1
Pharmacologic Class
Typical Antipsychotic - [EPC] (Established Pharmacologic Class)
Usage Information
Haloperidol is used to treat certain mental/mood disorders (e.g., schizophrenia, schizoaffective disorders). This medicine helps you to think more clearly, feel less nervous, and take part in everyday life. It can also help 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 can also be used to treat uncontrolled movements and outbursts of words/sounds related to Tourette's syndrome. Haloperidol is also used for severe behavior problems in hyperactive children when other treatments or medications have not worked. Haloperidol is a psychiatric medication (antipsychotic-type) that works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).

Regulatory & Marketing

Labeler Name
Mylan Pharmaceuticals Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA070278
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-17-2009
End Marketing Date
07-31-2026
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 0378-0334-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Haloperidol, a human prescription drug labeled by Mylan Pharmaceuticals Inc.. This tablet is formulated for oral use and contains haloperidol 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 Mylan Pharmaceuticals Inc. on July 17, 2009.

What are the primary indications for this medication?

Haloperidol is used to treat certain mental/mood disorders (e.g., schizophrenia, schizoaffective disorders). This medicine helps you to think more clearly, feel less nervous, and take part in everyday life. It can also help 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 can also be used to treat uncontrolled movements and outbursts of words/sounds related to Tourette's syndrome. Haloperidol is also used for severe behavior problems in hyperactive children when other treatments or medications have not worked. Haloperidol is a psychiatric medication (antipsychotic-type) that works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00378033401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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 (4-4-2)
0378-0334-01
11-Digit CMS (5-4-2)
00378-0334-01

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