Pioglitazone

Product NDC
53002-2757
11-digit product format
530022757
Labeler code
53002
Product ID
53002-2757_4657b69e-34a5-4ee5-931a-894e6f74ebb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA077210
Marketing category
ANDA
Marketing start
2015-05-22
Marketing end
0000-00-00
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
45 mg/1
Pharmacologic classes
Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312441pioglitazone 45 MG Oral TabletPSN3b4ee4b1-1048-4ab3-8997-6d05c05903a93
312441pioglitazone 45 MG Oral TabletSCD3b4ee4b1-1048-4ab3-8997-6d05c05903a93
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY3b4ee4b1-1048-4ab3-8997-6d05c05903a93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2757-35300227570330 TABLET in 1 BOTTLE (53002-2757-3) 30 tablet2020-01-010000-00-00NoNoCurrent
53002-2757-95300227570990 TABLET in 1 BOTTLE (53002-2757-9) 90 tablet2020-01-010000-00-00NoNoCurrent