Pioglitazone

Product NDC
71610-495
11-digit product format
716100495
Labeler code
71610
Product ID
71610-495_35580504-c655-4630-8432-b54e6c71218d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA200268
Marketing category
ANDA
Marketing start
2013-02-13
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
15 mg/1
Pharmacologic classes
PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
JQT35NPK6CPIOGLITAZONE HYDROCHLORIDE112529-15-4PIOGLITAZONE HYDROCHLORIDE
X4OV71U42SPIOGLITAZONE111025-46-8Pioglitazone

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-495-607161004956090 TABLET in 1 BOTTLE (71610-495-60) 90 tablet2020-11-17NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
PioglitazoneAphena Pharma Solutions - Tennessee, LLC2020-12-16Human Prescription Drug Label1