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

11-digit billing NDC: 68083047601
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Fluphenazine Decanoate injection is a long-acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronic schizophrenics).Fluphenazine Decanoate Injection has not been shown effective in the management of behavioral complications in patients with mental retardation. 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
Fluphenazine Decanoate Injection is a long-acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronic schizophrenics).Fluphenazine Decanoate Injection has not been shown effective in the management of behavioral complications 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
12-31-2027
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, 2027.

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.