Active ingredient
Pioglitazone
68 finished FDA listings contain Pioglitazone as their only active ingredient; 25 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- PIOGLITAZONE, PIOGLITAZONE HYDROCHLORIDE
- Dosage forms
- Tablet
- Routes
- Oral
- Manufacturers / labelers
- 23
- Strengths listed
- 15 mg/1 · 30 mg/1 · 45 mg/1
- Brand names in FDA listings
- Actos
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 33738
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 021073 | TAKEDA PHARMS USA | 1999-07-15 | 3 |
| ANDA 076798 | CHARTWELL RX | 2012-10-26 | 3 |
| ANDA 202467 | MACLEODS PHARMS LTD | 2013-02-06 | 11 |
| ANDA 200268 | AUROBINDO PHARMA LTD | 2013-02-13 | 31 |
| ANDA 077210 | TEVA PHARMS USA | 2014-01-10 | 11 |
| ANDA 207806 | PRINSTON INC | 2018-04-17 | 3 |
| ANDA 210165 | COREPHARMA | 2021-01-22 | 6 |
Official labeling on DailyMed
- PIOGLITAZONE TABLET [PREFERRED PHARMACEUTICALS INC.] · version 1 · 2026-08-31
- PIOGLITAZONE TABLET [PREFERRED PHARMACEUTICALS, INC.] · version 7 · 2026-08-19
- PIOGLITAZONE TABLET [PREFERRED PHARMACEUTICALS, INC.] · version 8 · 2026-08-19
- PIOGLITAZONE HYDROCHLORIDE TABLET [UNICHEM PHARMACEUTICALS (USA), INC.] · version 1 · 2026-06-26
- PIOGLITAZONE HYDROCHLORIDE TABLET [GSMS, INCORPORATED] · version 2 · 2026-06-22
- PIOGLITAZONE TABLET [MAJOR PHARMACEUTICALS] · version 5 · 2026-06-15
- PIOGLITAZONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] · version 5 · 2026-03-26
- PIOGLITAZONE TABLET [BRYANT RANCH PREPACK] · version 103 · 2026-03-10
- PIOGLITAZONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] · version 4 · 2026-03-04
- PIOGLITAZONE TABLET [BRYANT RANCH PREPACK] · version 101 · 2026-02-13
- PIOGLITAZONE TABLET [REMEDYREPACK INC.] · version 9 · 2026-02-11
- PIOGLITAZONE TABLET [REMEDYREPACK INC.] · version 12 · 2026-02-02
Showing the 12 most recent of 41 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.