Quick answers
- What is Fluphenazine hydrochloride used for?
- The FDA-approved label (Fluphenazine Hydrochoride, Remedyrepack Inc., July 3, 2026) says: “Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Fluphenazine hydrochloride have a boxed warning?
- Yes. The FDA label for Fluphenazine Hydrochoride has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Fluphenazine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Fluphenazine hydrochloride been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started August 25, 2026 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Fluphenazine hydrochloride?
- 28 companies list prescription products of Fluphenazine hydrochloride in the FDA NDC Directory, including Upsher-Smith Laboratories, LLC, Lannett Company, Inc. and Major Pharmaceuticals.
What Fluphenazine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.
— FDA label: Fluphenazine Hydrochoride, Remedyrepack Inc., effective July 3, 2026. Read the full label on DailyMed →
The FDA has 35 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
35 of 35 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Injection, solution · Solution, concentrate · Elixir |
|---|---|
| Route | Oral · Intramuscular |
| Prescription products | 107 in the FDA NDC Directory |
| Brand names | Fluphenazine Hydrochoride |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| fluphenazine hydrochloride 1 mg tablet | Generic | $0.2371 per tablet |
| fluphenazine hydrochloride 1 mg tablet, film coated | Generic | $0.2371 per tablet |
| fluphenazine hydrochloride 10 mg tablet | Generic | $0.3898 per tablet |
| fluphenazine hydrochloride 10 mg tablet, film coated | Generic | $0.3898 per tablet |
| fluphenazine hydrochloride 2.5 mg tablet | Generic | $0.2476 per tablet |
| fluphenazine hydrochloride 2.5 mg tablet, film coated | Generic | $0.2476 per tablet |
| fluphenazine hydrochloride 5 mg tablet | Generic | $0.2363 per tablet |
| fluphenazine hydrochloride 5 mg tablet, film coated | Generic | $0.2363 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Upsher-Smith Laboratories, LLC8 products
- Lannett Company, Inc.4 products
- Major Pharmaceuticals4 products
- Ajanta Pharma USA Inc.4 products
- Dr.Reddys Laboratories Inc4 products
- Alembic Pharmaceuticals Limited4 products
- AvPAK4 products
- Zydus Lifesciences Limited4 products
- Zameer Pharmaceuticals LLC4 products
- Camber Pharmaceuticals, Inc.4 products
- Golden State Medical Supply, Inc.4 products
- Sun Pharmaceutical Industries, Inc.4 products
- Zydus Pharmaceuticals USA Inc.4 products
- Proficient Rx LP4 products
- Marlex Pharmaceuticals, Inc.4 products
- Aurobindo Pharma Limited4 products
- Amneal Pharmaceuticals NY LLC4 products
- ANI Pharmaceuticals, Inc.4 products
- Rising Pharma Holdings, Inc.4 products
- Chartwell RX, LLC4 products
- Glenmark Pharmaceuticals Inc., USA4 products
- Alembic Pharmaceuticals Inc.4 products
- Novadoz Pharmaceuticals LLC4 products
- Coupler LLC3 products
- Remedyrepack Inc.3 products
- American Health Packaging2 products
- PAI Holdings, LLC dba PAI Pharma2 products
- Fresenius Kabi USA, LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (19)
- ANDA089556Fresenius Kabi USA · April 16, 1987
- ANDA089743Lannett Co Inc · August 25, 1988
- ANDA040146Pharm Assoc · August 21, 1996
- ANDA074725Pharm Assoc · September 16, 1996
- ANDA213647Amneal · July 9, 2020
- ANDA214534DR Reddys · January 7, 2021
- ANDA214674Novitium Pharma · March 1, 2021
- ANDA214552Zydus Lifesciences · May 27, 2021
- ANDA215141Chartwell Rx · October 20, 2021
- ANDA215848Twi Pharms · April 1, 2022
- ANDA215674Taro · April 14, 2022
- ANDA213784Upsher Smith Labs · October 24, 2022
- ANDA217410Ajanta Pharma Ltd · January 5, 2023
- ANDA218055Aurobindo Pharma Ltd · August 18, 2023
- ANDA217189Msn · September 11, 2023
- ANDA216350Glenmark Pharms Ltd · November 6, 2023
- ANDA218283Rising · June 7, 2024
- ANDA218173Alembic · July 23, 2024
- ANDA218769Hetero Labs Ltd III · November 18, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 25, 2026 · Class III · Ongoing · D-0836-2026
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01. — Ajanta Pharma USA Inc
-
March 13, 2025 · Class II · Ongoing · D-0326-2025
CGMP Deviations
Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah — Glenmark Pharmaceuticals Inc., USA
-
March 13, 2025 · Class II · Ongoing · D-0327-2025
CGMP Deviations
Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah — Glenmark Pharmaceuticals Inc., USA
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Fluphenazine Hydrochoride, Remedyrepack Inc., effective July 3, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →