Fluphenazine Decanoate Injection, Solution
NDC Package 72162-2635-2

11-digit billing NDC: 72162263502 · Billing unit: ML · 5 ML per package
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). This formulation utilizes a injection, solution delivery system. Marketed by Bryant Ranch Prepack, this product is identified by NDC 72162-2635 and is authorized under FDA application ANDA215365.

Identification & Billing

NDC Package Code
72162-2635-2
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 5 mL in 1 VIAL, MULTI-DOSE
Product Code
72162-2635
11-Digit Billing Format
72162263502
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
5 ML
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
Bryant Ranch Prepack
Product Type
Human Prescription Drug
FDA Application #
ANDA215365
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-02-2023
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 72162-2635-2 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 Bryant Ranch Prepack. This product is billed per "ML" milliliter and contains an estimated amount of 5 billable units per package. 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 Bryant Ranch Prepack on November 02, 2023. The current certification is valid through December 31, 2027.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72162263502. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 5 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 (5-4-1)
72162-2635-2
11-Digit CMS (5-4-2)
72162-2635-02

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