Fluphenazine Decanoate Injection
NDC Package 0143-9529-01
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 delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0143-9529 and is authorized under FDA application ANDA074531.
Identification & Billing
- RxCUI: 859824 - fluPHENAZine decanoate 25 MG/ML Injectable Solution
- RxCUI: 859824 - fluphenazine decanoate 25 MG/ML Injectable Solution
Clinical Specifications
- Intramuscular - Administration within a muscle.
- Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Regulatory & Marketing
Hierarchy Structure
- 0143 - Hikma Pharmaceuticals Usa Inc.
- 0143-9529 - Fluphenazine Decanoate
- 0143-9529-01 - 1 VIAL, MULTI-DOSE in 1 BOX / 5 mL in 1 VIAL, MULTI-DOSE
- 0143-9529 - Fluphenazine Decanoate
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.
Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
* 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 0143-9529-01 identifies a specific commercial package of 1 vial, multi-dose in 1 box / 5 ml in 1 vial, multi-dose of Fluphenazine Decanoate, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This injection 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 Hikma Pharmaceuticals Usa Inc. on August 30, 1996. 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 Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00143952901. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.