FDA.reportPublic FDA data

NDC 64764-0301 - Actos

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
64764-0301
Manufacturer
Rebel Distributors Corp.
Effective date
2010-09-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ACTOS ® (pioglitazone hydrochloride) TabletsRebel Distributors Corp.2010-09-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
pioglitazone hydrochlorideACTIVE INGREDIENTJQT35NPK6CACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP.]7
pioglitazoneACTIVE MOIETYX4OV71U42SACTOS (PIOGLITAZONE HYDROCHLORIDE) TABLET [REBEL DISTRIBUTORS CORP.]7

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 3 · 54 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pioglitazone and metformin hydrochloridePIOGLITAZONE AND METFORMIN HYDROCHLORIDEBryant Ranch Prepack8080eedb-e955-4059-98b2-9685b608eb3e2025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEChartwell RX, LLC699e865a-952e-459e-a871-9b7cce475b712025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312441
rxcui: 312440
rxcui: 317573
unii: JQT35NPK6C
Alogliptin and PioglitazoneALOGLIPTIN BENZOATE AND PIOGLITAZONE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd642b1e90-701e-42f2-bac6-a4918738e2c92025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEBryant Ranch Prepackc9548800-4c44-473d-a89b-c705484548b32025-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312440
unii: JQT35NPK6C
PioglitazonePIOGLITAZONEBryant Ranch Prepack6397fb4c-081b-4abd-ab4b-0a3fbf99e6632025-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312440
unii: JQT35NPK6C
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEAurobindo Pharma Limited1f259863-21fd-4d62-b094-4eff845944df2025-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312441
rxcui: 312440
rxcui: 317573
unii: JQT35NPK6C
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEQUALLENT PHARMACEUTICALS HEALTH LLC0331400c-b163-4856-bfb0-965470247cb32025-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312441
rxcui: 312440
rxcui: 317573
unii: JQT35NPK6C
PioglitazonePIOGLITAZONERising Pharma Holdings, Inc.4483b1c6-7095-4a63-8128-ac2d91e110402025-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312441
rxcui: 312440
rxcui: 317573
unii: JQT35NPK6C
Pioglitazole and metformin hydrochloridePIOGLITAZOLE AND METFORMIN HYDROCHLORIDEBryant Ranch Prepack7418254e-7232-466f-9d6b-4743b0bba2a12025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
Pioglitazole and metformin hydrochloridePIOGLITAZOLE AND METFORMIN HYDROCHLORIDEBryant Ranch Prepackbd9c05c9-278f-498d-881c-29ba1b60596e2025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
ActosPIOGLITAZONETakeda Pharmaceuticals America, Inc.d2ddc491-88a9-4063-9150-443b4fa4330c2025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA021073
ndc (product): 64764-151
rxcui: 312441
rxcui: 261266
rxcui: 312440
rxcui: 261268
rxcui: 261267
rxcui: 317573
spl id: 20e43dff-4bf2-4ae7-82a1-e7e895123f93
spl set id: d2ddc491-88a9-4063-9150-443b4fa4330c
unii: JQT35NPK6C
DuetactPIOGLITAZONE AND GLIMEPIRIDETakeda Pharmaceuticals America, Inc.f8b0c917-3fdd-4a28-a47d-6225b81954582025-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.31619517-a590-408a-ae9e-76c99f0a0a1d2025-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312441
rxcui: 312440
rxcui: 317573
unii: JQT35NPK6C
OSENIALOGLIPTIN AND PIOGLITAZONETakeda Pharmaceuticals America, Inc.4c619ed9-fe3e-4158-9938-80c6c3493d552025-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
Pioglitazone Hydrochloride and Metformin HydrochloridePIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDERising Pharma Holdings, Inc.8d252dab-e868-42d3-95ea-69423d909e842025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
PIOGLITAZONEPIOGLITAZONEDIRECT RXa7e8d5a3-b0da-1d70-e053-2a95a90aa4352025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312440
unii: JQT35NPK6C
PioglitazonePIOGLITAZONENuCare Pharmaceuticals,Inc.bde7fa79-aafc-3ba0-e053-2a95a90aa4d22025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312440
unii: JQT35NPK6C
PioglitazonePIOGLITAZONEBryant Ranch Prepackf6cad01e-cd65-4c8d-9e49-399404f220052024-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317573
unii: JQT35NPK6C
PioglitazonePIOGLITAZONENuCare Pharmaceuticals,Inc.af863b9e-9646-3b1e-e053-2995a90ab93a2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312440
unii: JQT35NPK6C
PioglitazonePIOGLITAZONENuCare Pharmaceuticals,Inc.a4751cb4-0700-dd22-e053-2995a90adfdb2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317573
unii: JQT35NPK6C

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.