Pioglitazone Hydrochloride

Product NDC
52343-053
11-digit product format
523430053
Labeler code
52343
Product ID
52343-053_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
15 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
52343-053-05EA - Each52343-0533587d53a-3dbb-4b9c-9851-a6893cba898412014-02-04
52343-053-30EA - Each52343-05336494a8c-a032-48ce-a267-21f9c4361a2b12014-02-04
52343-053-90EA - Each52343-053e40ed780-0ffe-4700-8014-183d4977f6e112014-02-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52343-053-0552343005305500 TABLET in 1 BOTTLE (52343-053-05) 500 tablet2013-02-130000-00-00NoNoCurrent
52343-053-305234300533030 TABLET in 1 BOTTLE (52343-053-30) 30 tablet2013-02-130000-00-00NoNoCurrent
52343-053-905234300539090 TABLET in 1 BOTTLE (52343-053-90) 90 tablet2013-02-130000-00-00NoNoCurrent