Active ingredient
Fluoxetine
227 finished FDA listings contain Fluoxetine as their only active ingredient; 15 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- FLUOXETINE, FLUOXETINE HYDROCHLORIDE
- Dosage forms
- Capsule, Capsule, Delayed Release Pellets, For Solution, Liquid, Solution, Tablet, Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 61
- Strengths listed
- 10 mg/1 · 20 mg/1 · 20 mg/5ml · 40 mg/1 · 60 mg/1 · 90 mg/1
- Brand names in FDA listings
- Fluoxetine, Prozac
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 4493
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 |
|---|---|---|---|
| NDA 018936 | ELI LILLY AND CO | 1987-12-29 | 3 |
| ANDA 075465 | MARKSANS PHARMA | 2002-01-29 | 7 |
| ANDA 076001 | TEVA PHARMS USA | 2002-01-29 | 16 |
| ANDA 075452 | TEVA | 2002-01-29 | 2 |
| ANDA 076006 | DR REDDYS | 2002-01-30 | 4 |
| ANDA 076015 | PHARM ASSOC | 2002-01-30 | 2 |
| ANDA 075525 | SCIEGEN PHARMS | 2002-06-27 | 1 |
| ANDA 076458 | CHARTWELL MOLECULAR | 2004-05-14 | 2 |
| ANDA 077849 | LANNETT CO INC | 2007-02-09 | 1 |
| ANDA 078619 | AUROBINDO PHARMA | 2008-01-31 | 67 |
| ANDA 090223 | ALEMBIC PHARMS LTD | 2009-03-19 | 7 |
| ANDA 079209 | AUROBINDO PHARMA | 2009-03-19 | 2 |
| ANDA 078572 | DR REDDYS LABS LTD | 2010-03-22 | 1 |
| ANDA 201336 | HERITAGE | 2012-10-01 | 4 |
| ANDA 204597 | SCIEGEN PHARMS | 2015-03-16 | 54 |
| ANDA 203836 | PH HEALTH | 2016-08-19 | 9 |
| ANDA 206937 | TORRENT | 2016-10-21 | 2 |
| ANDA 208698 | ALEMBIC | 2017-04-05 | 5 |
| ANDA 209419 | PH HEALTH | 2017-11-16 | 3 |
| ANDA 211477 | SOMERSET THERAPS LLC | 2018-11-21 | 1 |
| ANDA 211282 | SCIEGEN PHARMS | 2019-01-10 | 2 |
| ANDA 211721 | DR REDDYS | 2019-01-25 | 2 |
| ANDA 211632 | LUPIN | 2019-02-08 | 1 |
| ANDA 210935 | SCIEGEN PHARMS | 2019-03-20 | 2 |
| ANDA 211653 | LUPIN | 2019-04-15 | 2 |
| ANDA 206993 | CADILA PHARMS LTD | 2019-05-23 | 8 |
| ANDA 213286 | AUROBINDO PHARMA LTD | 2020-04-08 | 8 |
| ANDA 213265 | AUROBINDO PHARMA LTD | 2020-06-10 | 3 |
| ANDA 216448 | NOVITIUM PHARMA | 2022-11-09 | 1 |
| ANDA 216953 | UPSHER SMITH LABS | 2022-11-15 | 1 |
| ANDA 212684 | STRIDES PHARMA | 2024-04-05 | 3 |
| ANDA 212683 | STRIDES PHARMA | 2024-09-13 | 1 |
Official labeling on DailyMed
- FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REMEDYREPACK INC.] · version 3 · 2026-09-14
- FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [MAJOR PHARMACEUTICALS] · version 5 · 2026-09-10
- FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [SCIEGEN PHARMACEUTICALS, INC.] · version 16 · 2026-08-21
- FLUOXETINE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] · version 20 · 2026-08-13
- FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] · version 1 · 2026-08-07
- FLUOXETINE HYDROCHLORIDE CAPSULE, DELAYED RELEASE PELLETS [DR.REDDY'S LABORATORIES LIMITED] · version 21 · 2026-08-06
- FLUOXETINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 2 · 2026-07-21
- FLUOXETINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] · version 2 · 2026-07-21
- FLUOXETINE HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK] · version 103 · 2026-07-20
- FLUOXETINE HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK] · version 102 · 2026-07-20
- FLUOXETINE CAPSULE [REMEDYREPACK INC.] · version 9 · 2026-07-20
- FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 6 · 2026-07-16
Showing the 12 most recent of 165 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.