Quick answers
- What is Pioglitazone used for?
- The FDA-approved label (Actos, Takeda Pharmaceuticals America, Inc., March 28, 2025) says: “Monotherapy and Combination Therapy ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings […]. Important Limitations of Use ACTOS exerts its antihyperglycemic effect only in the presence of endogenous insulin. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pioglitazone have a boxed warning?
- Yes. The FDA label for Actos has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Pioglitazone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pioglitazone been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started December 29, 2021 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Pioglitazone?
- 22 companies list prescription products of Pioglitazone in the FDA NDC Directory, including A-S Medication Solutions, NuCare Pharmaceuticals, Inc. and Bryant Ranch Prepack.
What Pioglitazone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Monotherapy and Combination Therapy ACTOS is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings […]. Important Limitations of Use ACTOS exerts its antihyperglycemic effect only in the presence of endogenous insulin. …
— FDA label: Actos, Takeda Pharmaceuticals America, Inc., effective March 28, 2025. Read the full label on DailyMed →
The FDA has 41 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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 →
41 of 41 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 68 in the FDA NDC Directory |
| Brand names | Actos |
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 |
|---|---|---|
| pioglitazone hydrochloride 15 mg tablet | Generic | $0.0697 per tablet |
| pioglitazone hydrochloride 30 mg tablet | Generic | $0.0965 per tablet |
| pioglitazone hydrochloride 45 mg tablet | Generic | $0.1163 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.
- A-S Medication Solutions8 products
- NuCare Pharmaceuticals, Inc.6 products
- Bryant Ranch Prepack5 products
- Rising Pharma Holdings, Inc.3 products
- Takeda Pharmaceuticals America, Inc.3 products
- GSMS, Incorporated3 products
- NorthStar RxLLC3 products
- Chartwell RX, LLC3 products
- Unichem Pharmaceuticals (USA), Inc.3 products
- Macleods Pharmaceuticals Limited3 products
- Preferred Pharmaceuticals Inc.3 products
- Quallent Pharmaceuticals Health LLC3 products
- Teva Pharmaceuticals USA, Inc.3 products
- Aurobindo Pharma Limited3 products
- Remedyrepack Inc.3 products
- AvKARE3 products
- Solco Healthcare LLC3 products
- Major Pharmaceuticals2 products
- American Health Packaging2 products
- Proficient Rx LP1 product
- Direct_Rx1 product
- Aphena Pharma Solutions - Tennessee, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021073 ACTOS | Takeda Pharms USA | July 15, 1999 | 40, latest December 21, 2017 2017: Labeling · 2016: Efficacy · 2013: Labeling |
Generic approvals (6)
- ANDA076798Chartwell Rx · October 26, 2012
- ANDA202467Macleods Pharms Ltd · February 6, 2013
- ANDA200268Aurobindo Pharma Ltd · February 13, 2013
- ANDA077210Teva Pharms USA · January 10, 2014
- ANDA207806Prinston Inc · April 17, 2018
- ANDA210165Solgen · January 22, 2021
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.
-
December 29, 2021 · Class II · Terminated · D-0450-2022
Superpotent and Failed Tablet/Capsule Specifications
Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05 — Aurobindo Pharma USA Inc.
-
September 23, 2019 · Class II · Terminated · D-0140-2020
Superpotent
Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India NDC 333 — Macleods Pharma Usa Inc
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) — Actos, Takeda Pharmaceuticals America, Inc., effective March 28, 2025; 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 →