Pioglitazone Hydrochloride

Product NDC
52343-055
11-digit product format
523430055
Labeler code
52343
Product ID
52343-055_62b88c63-8045-4a1e-92b1-4ae0cc6a8354
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
ACETRIS HEALTH, LLC
Application
ANDA200268
Marketing category
ANDA
Marketing start
2013-02-13
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52343-055-05EA - Each52343-055ff408bf4-e2f4-4e67-9e3f-edcf3750e9f812014-02-04
52343-055-30EA - Each52343-055bb9cd4e2-bbf9-4594-8cd3-616940b14e6e12014-02-04
52343-055-90EA - Each52343-055a48016b2-c234-4125-88fe-218549445a3c12014-02-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52343-055-0552343005505500 TABLET in 1 BOTTLE (52343-055-05) 500 tablet2013-02-130000-00-00NoNoCurrent
52343-055-305234300553030 TABLET in 1 BOTTLE (52343-055-30) 30 tablet2013-02-130000-00-00NoNoCurrent
52343-055-905234300559090 TABLET in 1 BOTTLE (52343-055-90) 90 tablet2013-02-130000-00-00NoNoCurrent