Active ingredient
Aripiprazole
268 finished FDA listings contain Aripiprazole as their only active ingredient.
At a glance
From the FDA NDC Directory
- Ingredient names as written by FDA
- ARIPIPRAZOLE, ARIPIPRAZOLE MONOHYDRATE
- Dosage forms
- Film, Soluble, Injection, Suspension, Extended Release, Solution, Tablet, Tablet, Orally Disintegrating
- Routes
- Intramuscular, Oral
- Manufacturers / labelers
- 50
- Strengths listed
- 1 mg/ml · 10 mg/1 · 15 mg/1 · 2 mg/1 · 20 mg/1 · 30 mg/1 · 5 mg/1 · 720 mg/2.4ml · 960 mg/3.2ml
- Brand names in FDA listings
- Abilify, Abilify Asimtufii, Aripiprazole, Opipza
Official drug information
Source coverage for Aripiprazole:
- FDA NDC Directory: linked
- RxNorm: linked
- Drugs@FDA: linked
- DailyMed: linked
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 89013
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
- NDA 021436
- Sponsor
- OTSUKA
- Original approval
- 2002-11-15
- Listings
- 6
- Application
- ANDA 205064
- Sponsor
- HETERO LABS LTD V
- Original approval
- 2015-04-28
- Listings
- 56
- Application
- ANDA 201519
- Sponsor
- TORRENT
- Original approval
- 2015-04-28
- Listings
- 18
- Application
- ANDA 202101
- Sponsor
- ALEMBIC
- Original approval
- 2015-04-28
- Listings
- 18
- Application
- ANDA 202102
- Sponsor
- ALEMBIC
- Original approval
- 2015-04-28
- Listings
- 4
- Application
- ANDA 204171
- Sponsor
- LANNETT CO INC
- Original approval
- 2015-08-14
- Listings
- 1
- Application
- ANDA 203906
- Sponsor
- AMNEAL PHARMS
- Original approval
- 2015-08-14
- Listings
- 1
- Application
- ANDA 204094
- Sponsor
- APOTEX
- Original approval
- 2015-09-30
- Listings
- 1
- Application
- ANDA 203908
- Sponsor
- AUROBINDO PHARMA
- Original approval
- 2015-10-08
- Listings
- 13
- Application
- ANDA 204838
- Sponsor
- AMNEAL PHARMS
- Original approval
- 2016-06-17
- Listings
- 15
- Application
- ANDA 206174
- Sponsor
- AJANTA PHARMA LTD
- Original approval
- 2016-09-12
- Listings
- 18
- Application
- ANDA 206383
- Sponsor
- SCIEGEN PHARMS
- Original approval
- 2016-09-29
- Listings
- 27
- Application
- ANDA 204111
- Sponsor
- MACLEODS PHARMS
- Original approval
- 2016-10-07
- Listings
- 6
- Application
- ANDA 206251
- Sponsor
- ACCORD HLTHCARE
- Original approval
- 2016-12-07
- Listings
- 7
- Application
- ANDA 205363
- Sponsor
- PRINSTON INC
- Original approval
- 2017-12-04
- Listings
- 13
- Application
- ANDA 202547
- Sponsor
- ORBION PHARMS
- Original approval
- 2017-12-11
- Listings
- 2
- Application
- ANDA 207240
- Sponsor
- SCIEGEN PHARMS
- Original approval
- 2018-04-18
- Listings
- 4
- Application
- ANDA 090165
- Sponsor
- SQUARE PHARMS
- Original approval
- 2018-08-28
- Listings
- 6
- Application
- ANDA 210479
- Sponsor
- AUROBINDO PHARMA LTD
- Original approval
- 2019-01-29
- Listings
- 1
- Application
- ANDA 207105
- Sponsor
- ALKEM LABS LTD
- Original approval
- 2019-02-21
- Listings
- 31
- Application
- ANDA 212870
- Sponsor
- VISTAPHARM LLC
- Original approval
- 2019-12-26
- Listings
- 1
- Application
- ANDA 203025
- Sponsor
- UNICHEM
- Original approval
- 2021-12-01
- Listings
- 6
- Application
- ANDA 215595
- Sponsor
- CHARTWELL RX
- Original approval
- 2022-10-25
- Listings
- 1
- Application
- ANDA 216351
- Sponsor
- RUBICON RESEARCH
- Original approval
- 2022-10-27
- Listings
- 1
- Application
- NDA 217006
- Sponsor
- OTSUKA
- Original approval
- 2023-04-27
- Listings
- 2
- Application
- ANDA 216150
- Sponsor
- HETERO LABS LTD III
- Original approval
- 2023-11-01
- Listings
- 3
- Application
- NDA 216655
- Sponsor
- XIAMEN LP PHARM CO
- Original approval
- 2024-07-22
- Listings
- 3
- Application
- ANDA 215582
- Sponsor
- QUAGEN
- Original approval
- 2025-10-22
- Listings
- 1
- Application
- ANDA 216208
- Sponsor
- AUROBINDO PHARMA
- Original approval
- 2026-02-18
- Listings
- 2
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021436 | OTSUKA | 2002-11-15 | 6 |
| ANDA 205064 | HETERO LABS LTD V | 2015-04-28 | 56 |
| ANDA 201519 | TORRENT | 2015-04-28 | 18 |
| ANDA 202101 | ALEMBIC | 2015-04-28 | 18 |
| ANDA 202102 | ALEMBIC | 2015-04-28 | 4 |
| ANDA 204171 | LANNETT CO INC | 2015-08-14 | 1 |
| ANDA 203906 | AMNEAL PHARMS | 2015-08-14 | 1 |
| ANDA 204094 | APOTEX | 2015-09-30 | 1 |
| ANDA 203908 | AUROBINDO PHARMA | 2015-10-08 | 13 |
| ANDA 204838 | AMNEAL PHARMS | 2016-06-17 | 15 |
| ANDA 206174 | AJANTA PHARMA LTD | 2016-09-12 | 18 |
| ANDA 206383 | SCIEGEN PHARMS | 2016-09-29 | 27 |
| ANDA 204111 | MACLEODS PHARMS | 2016-10-07 | 6 |
| ANDA 206251 | ACCORD HLTHCARE | 2016-12-07 | 7 |
| ANDA 205363 | PRINSTON INC | 2017-12-04 | 13 |
| ANDA 202547 | ORBION PHARMS | 2017-12-11 | 2 |
| ANDA 207240 | SCIEGEN PHARMS | 2018-04-18 | 4 |
| ANDA 090165 | SQUARE PHARMS | 2018-08-28 | 6 |
| ANDA 210479 | AUROBINDO PHARMA LTD | 2019-01-29 | 1 |
| ANDA 207105 | ALKEM LABS LTD | 2019-02-21 | 31 |
| ANDA 212870 | VISTAPHARM LLC | 2019-12-26 | 1 |
| ANDA 203025 | UNICHEM | 2021-12-01 | 6 |
| ANDA 215595 | CHARTWELL RX | 2022-10-25 | 1 |
| ANDA 216351 | RUBICON RESEARCH | 2022-10-27 | 1 |
| NDA 217006 | OTSUKA | 2023-04-27 | 2 |
| ANDA 216150 | HETERO LABS LTD III | 2023-11-01 | 3 |
| NDA 216655 | XIAMEN LP PHARM CO | 2024-07-22 | 3 |
| ANDA 215582 | QUAGEN | 2025-10-22 | 1 |
| ANDA 216208 | AUROBINDO PHARMA | 2026-02-18 | 2 |
Official labeling on DailyMed
- ARIPIPRAZOLE TABLET [REMEDYREPACK INC.] · version 1 · 2026-09-10
- ARIPIPRAZOLE SOLUTION [APOTEX CORP.] · version 17 · 2026-09-07
- ARIPIPRAZOLE TABLET [COUPLER LLC] · version 1 · 2026-08-06
- ARIPIPRAZOLE TABLET [AUROBINDO PHARMA LIMITED] · version 18 · 2026-08-03
- ARIPIPRAZOLE TABLET [REMEDYREPACK INC.] · version 12 · 2026-08-03
- ARIPIPRAZOLE TABLET [REMEDYREPACK INC.] · version 13 · 2026-08-03
- ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED] · version 2 · 2026-08-03
- ARIPIPRAZOLE TABLET [REMEDYREPACK INC.] · version 16 · 2026-07-31
- ARIPIPRAZOLE TABLET [REMEDYREPACK INC.] · version 16 · 2026-07-31
- ARIPIPRAZOLE (ARIPIPRAZOLE ORALLY DISINTEGRATING) TABLET [DR. REDDY'S LABORATORIES INC] · version 9 · 2026-07-29
- ARIPIPRAZOLE TABLET [REMEDYREPACK INC.] · version 10 · 2026-07-28
- ARIPIPRAZOLE TABLET [REMEDYREPACK INC.] · version 6 · 2026-07-24
Showing the 12 most recent of 119 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.