FDA.reportPublic FDA data

NDC 51079-513-01 - Pioglitazone

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
51079-513
Requested NDC
51079-513-01
Package NDCs from labels
51079-513-01, 51079-513-20
Manufacturer
Mylan Institutional Inc.
Effective date
2018-12-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pioglitazone - Mylan Institutional Inc.Mylan Institutional Inc.2018-12-20HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-513-01EA - Each51079-5136b43d250-25dd-4e02-a6e2-3fe98ee719ff12013-02-13
51079-513-20EA - Each51079-5137a4be96e-e838-401c-9246-5031a911607f12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIOGLITAZONE HYDROCHLORIDEACTIVE INGREDIENTJQT35NPK6CPIOGLITAZONE TABLET [MYLAN INSTITUTIONAL INC.]2
PIOGLITAZONEACTIVE MOIETYX4OV71U42SPIOGLITAZONE TABLET [MYLAN INSTITUTIONAL INC.]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPIOGLITAZONE TABLET [MYLAN INSTITUTIONAL INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPIOGLITAZONE TABLET [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PIOGLITAZONE TABLET [MYLAN INSTITUTIONAL INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPIOGLITAZONE TABLET [MYLAN INSTITUTIONAL INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PIOGLITAZONE TABLET [MYLAN INSTITUTIONAL INC.]2

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 1 of 4 · 61 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pioglitazone Hydrochloride and Metformin HydrochloridePIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDEAurobindo Pharma Limited1fa2703e-fb73-44d5-aaa2-b12b1090d42c2026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
Pioglitazone HCL and Metformin HCLPIOGLITAZONE HCL AND METFORMIN HCLTorrent Pharmaceuticals Limited237d8fa2-633c-4c29-84d3-f1b413610dc32026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
PioglitazonePIOGLITAZONEPreferred Pharmaceuticals Inc.c748f901-8321-4dc2-8848-b7ed27f11f972026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
Actoplus MetPIOGLITAZONE AND METFORMIN HYDROCHLORIDETakeda Pharmaceuticals America, Inc.42e49120-6f3f-11db-9fe1-0800200c9a662026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
PioglitazonePIOGLITAZONEPreferred Pharmaceuticals, Inc.164c444c-7c56-4482-9cbd-0e0f0ad30c442026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
PioglitazonePIOGLITAZONEPreferred Pharmaceuticals, Inc.060e3169-46a7-419d-9acc-05586cb2406b2026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEGSMS, Incorporatedd740d2a2-b26d-4b16-aedc-e4b4b1c94daa2026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
PioglitazonePIOGLITAZONEMajor Pharmaceuticals72b46a1e-d9ea-4a47-95ef-5eae96ef1e7f2026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEA-S Medication Solutions6cd7c8b7-f5d4-423b-ae9f-86541869d8cf2026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
PioglitazonePIOGLITAZONEBryant Ranch Prepack466ef4c8-84d4-4ded-8505-a33f12adf31c2026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEA-S Medication Solutionse64b46e5-3c94-4635-908e-cdc2263bd3d42026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
PioglitazonePIOGLITAZONEBryant Ranch Prepackfbdaaa34-06c4-49af-85b4-91a85922b30b2026-02-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
PioglitazonePIOGLITAZONEREMEDYREPACK INC.3a9f6777-9b4f-482a-aa4e-4900f9d35b8e2026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
PioglitazonePIOGLITAZONEREMEDYREPACK INC.55f9b2d8-3e78-4e2f-bcf1-d00595078fa12026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEA-S Medication Solutions41a9586c-8768-4fc3-bb78-e6d98b09030b2026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
PioglitazonePIOGLITAZONEAvKARE22569835-bc9f-7787-e063-6394a90a62322026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
PioglitazonePIOGLITAZONEAmerican Health Packagingf3a2222d-5156-4533-bb4b-74652c8eb9c72026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEA-S Medication Solutions29073b0a-1d7e-4354-87c7-e764106978d82026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
pioglitazone and glimepiridePIOGLITAZONE AND GLIMEPIRIDEPrasco Laboratoriesea385b3d-cb4c-4550-97b0-93a86533f6dc2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C
Pioglitazone and metformin hydrochloridePIOGLITAZONE AND METFORMIN HYDROCHLORIDEBryant Ranch Prepack86ca843a-441b-488d-be1d-2576aeee19cf2025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JQT35NPK6C

Reported adverse events (FAERS/openFDA)#

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