Fluphenazine Decanoate Injection, Solution
NDC Package 68083-476-01

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

Package Information

Fluphenazine Decanoate injection is a medication a long-acting form of fluphenazine that is used to treat certain mental/mood problems (chronic schizophrenia). This formulation utilizes a injection, solution delivery system. Marketed by Gland Pharma Limited, this product is identified by NDC 68083-476 and is authorized under FDA application ANDA215509.

Identification & Billing

NDC Package Code
68083-476-01
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE
Product Code
68083-476
11-Digit Billing Format
68083047601
RxNorm Crosswalk
  • RxCUI: 859824 - fluPHENAZine decanoate 25 MG/ML Injectable Solution
  • RxCUI: 859824 - fluphenazine decanoate 25 MG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Fluphenazine Decanoate
Non-Proprietary Name
Fluphenazine Decanoate
Substance Name
Fluphenazine Decanoate
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
FLUPHENAZINE DECANOATE 25 mg/mL
Pharmacologic Class
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
Gland Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA215509
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
03-30-2023
Listing Expiration
12-31-2026
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 68083-476-01 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 5 ml in 1 vial, multi-dose of Fluphenazine Decanoate, a human prescription drug labeled by Gland Pharma Limited. This injection, solution is formulated for intramuscular; subcutaneous 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 Gland Pharma Limited on March 30, 2023. 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 Gland Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68083047601. 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)
68083-476-01
11-Digit CMS (5-4-2)
68083-0476-01

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