Pioglitazone Hydrochloride

Product NDC
63629-3330
11-digit product format
636293330
Labeler code
63629
Product ID
63629-3330_66717657-3760-463a-be2c-af6be7ed4e16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200044
Marketing category
ANDA
Marketing start
2013-02-13
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIOGLITAZONE HYDROCHLORIDEACTIVE INGREDIENTJQT35NPK6CPIOGLITAZONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
PIOGLITAZONEACTIVE MOIETYX4OV71U42SPIOGLITAZONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LPIOGLITAZONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
HYDROXYPROPYL CELLULOSE (TYPE E)INACTIVE INGREDIENT66O7AQV0RTPIOGLITAZONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPIOGLITAZONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PIOGLITAZONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-3330PIOGLITAZONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1010Legacy NDC20241109_66717657-3760-463a-be2c-af6be7ed4e16.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3330-16362933300130 TABLET in 1 BOTTLE (63629-3330-1) 30 tablet2014-04-280000-00-00NoNoCurrent
63629-3330-26362933300290 TABLET in 1 BOTTLE (63629-3330-2) 90 tablet2014-04-280000-00-00NoNoCurrent
63629-3330-36362933300360 TABLET in 1 BOTTLE (63629-3330-3) 60 tablet2014-06-260000-00-00NoNoCurrent
63629-3330-463629333004120 TABLET in 1 BOTTLE (63629-3330-4) 120 tablet2022-02-080000-00-00NoNoCurrent