Fluphenazine Decanoate Powder
NDC Package 69766-073-01

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 an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Fluphenazine Decanoate powders is a medication a long-acting form of fluphenazine that is used to treat certain mental/mood problems (chronic schizophrenia). This formulation utilizes a powder delivery system. Marketed by Msn Life Sciences Private Limited, this product is identified by NDC 69766-073.

Identification & Billing

NDC Package Code
69766-073-01
Package Description
50 kg in 1 DRUM
Product Code
69766-073
11-Digit Billing Format
69766007301

Clinical Specifications

Proprietary Name
Fluphenazine Decanoate
Non-Proprietary Name
Fluphenazine Decanoate
Substance Name
Fluphenazine Decanoate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Active Ingredient(s)
FLUPHENAZINE DECANOATE 1 kg/kg
Usage Information
This medication is a long-acting form of fluphenazine that is used to treat certain mental/mood problems (chronic schizophrenia). Fluphenazine decanoate is usually used in patients who have benefited from regular doses of short-acting forms of fluphenazine and who may benefit from long-term (maintenance) treatment with less frequent dosing. Fluphenazine belongs to a class of medications called phenothiazines and is also referred to as a neuroleptic. It works by affecting the balance of natural chemicals (neurotransmitters) in the brain. Some of the benefits of continued use of this medication include reduced episodes of hallucinations, delusions, or bizarre behaviors that occur in patients with schizophrenia. This product does not work right away. It may take 1-3 days to notice an effect from this drug, and up to 4 days to experience the full effect. For severe agitation or other symptoms, use a short-acting medication as directed by your doctor. This medication is not recommended for use in children under 12 years of age. Also, it should not be used to manage behavioral problems in patients with mental retardation.

Regulatory & Marketing

Labeler Name
Msn Life Sciences Private Limited
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
07-30-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 69766-073-01 identifies a specific commercial package of 50 kg in 1 drum of Fluphenazine Decanoate (UNFINISHED drug), a bulk ingredient labeled by Msn Life Sciences Private Limited. This powder is formulated for use and contains fluphenazine 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 Msn Life Sciences Private Limited on July 30, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is a long-acting form of fluphenazine that is used to treat certain mental/mood problems (chronic schizophrenia). Fluphenazine decanoate is usually used in patients who have benefited from regular doses of short-acting forms of fluphenazine and who may benefit from long-term (maintenance) treatment with less frequent dosing. Fluphenazine belongs to a class of medications called phenothiazines and is also referred to as a neuroleptic. It works by affecting the balance of natural chemicals (neurotransmitters) in the brain. Some of the benefits of continued use of this medication include reduced episodes of hallucinations, delusions, or bizarre behaviors that occur in patients with schizophrenia. This product does not work right away. It may take 1-3 days to notice an effect from this drug, and up to 4 days to experience the full effect. For severe agitation or other symptoms, use a short-acting medication as directed by your doctor. This medication is not recommended for use in children under 12 years of age. Also, it should not be used to manage behavioral problems in patients with mental retardation.

How is this Msn Life Sciences Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69766007301. 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)
69766-073-01
11-Digit CMS (5-4-2)
69766-0073-01

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