Active ingredient
Fluphenazine
117 finished FDA listings contain Fluphenazine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- FLUPHENAZINE DECANOATE, FLUPHENAZINE HYDROCHLORIDE
- Dosage forms
- Elixir, Injection, Injection, Solution, Solution, Concentrate, Tablet, Tablet, Film Coated
- Routes
- Intramuscular, Oral, Subcutaneous
- Manufacturers / labelers
- 36
- Strengths listed
- .5 mg/ml · 1 mg/1 · 10 mg/1 · 125 mg/5ml · 2.5 mg/1 · 2.5 mg/ml · 25 mg/ml · 5 mg/1 · 5 mg/ml
- Brand names in FDA listings
- Fluphenazine Hydrochoride
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 4496
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 089556 | FRESENIUS KABI USA | 1987-04-16 | 1 |
| ANDA 071413 | FRESENIUS KABI USA | 1987-07-14 | 1 |
| ANDA 089743 | LANNETT CO INC | 1988-08-25 | 8 |
| ANDA 040146 | PHARM ASSOC | 1996-08-21 | 1 |
| ANDA 074531 | HIKMA | 1996-08-30 | 1 |
| ANDA 074725 | PHARM ASSOC | 1996-09-16 | 1 |
| ANDA 075918 | MYLAN LABS LTD | 2001-08-17 | 1 |
| ANDA 203732 | PH HEALTH | 2014-07-03 | 2 |
| ANDA 207739 | EUGIA PHARMA | 2017-10-17 | 1 |
| ANDA 213647 | AMNEAL | 2020-07-09 | 5 |
| ANDA 214534 | DR REDDYS | 2021-01-07 | 14 |
| ANDA 214674 | NOVITIUM PHARMA | 2021-03-01 | 8 |
| ANDA 214552 | ZYDUS LIFESCIENCES | 2021-05-27 | 8 |
| ANDA 215141 | CHARTWELL RX | 2021-10-20 | 8 |
| ANDA 215848 | TWI PHARMS | 2022-04-01 | 8 |
| ANDA 215674 | TARO | 2022-04-14 | 5 |
| ANDA 213784 | UPSHER SMITH LABS | 2022-10-24 | 4 |
| ANDA 217410 | AJANTA PHARMA LTD | 2023-01-05 | 5 |
| ANDA 215509 | GLAND | 2023-03-30 | 2 |
| ANDA 218055 | AUROBINDO PHARMA LTD | 2023-08-18 | 4 |
| ANDA 217189 | MSN | 2023-09-11 | 4 |
| ANDA 215365 | MSN | 2023-11-02 | 2 |
| ANDA 216350 | GLENMARK PHARMS LTD | 2023-11-06 | 4 |
| ANDA 218283 | RISING | 2024-06-07 | 5 |
| ANDA 218173 | ALEMBIC | 2024-07-23 | 10 |
| ANDA 218769 | HETERO LABS LTD III | 2025-11-18 | 4 |
Official labeling on DailyMed
- FLUPHENAZINE DECANOATE INJECTION, SOLUTION [PAR HEALTH USA, LLC] · version 7 · 2026-08-28
- FLUPHENAZINE DECANOATE INJECTION, SOLUTION [PAR HEALTH USA, LLC] · version 14 · 2026-08-26
- FLUPHENAZINE DECANOATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] · version 2 · 2026-07-23
- FLUPHENAZINE HYDROCHORIDE (FLUPHENAZINE HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC.] · version 1 · 2026-07-06
- FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [COUPLER LLC] · version 1 · 2026-06-08
- FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.] · version 1 · 2026-06-03
- FLUPHENAZINE DECANOATE INJECTION, SOLUTION [BRYANT RANCH PREPACK] · version 100 · 2026-05-11
- FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] · version 13 · 2026-04-29
- FLUPHENAZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] · version 4 · 2026-04-27
- FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 5 · 2026-03-25
- FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] · version 5 · 2026-01-30
- FLUPHENAZINE HYDROCHLORIDE TABLET [AJANTA PHARMA USA INC.] · version 6 · 2026-01-06
Showing the 12 most recent of 45 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.