Pioglitazone

Product NDC
0781-5421
11-digit product format
007815421
Labeler code
0781
Product ID
0781-5421_114a7af7-cc48-4535-8b56-589941e5f521
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA078670
Marketing category
ANDA
Marketing start
2013-03-01
Marketing end
0000-00-00
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
30 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
0781-5421-10EA - Each0781-5421ce833cd5-7aab-4873-b07a-5a0f89c1e58812013-03-03
0781-5421-31EA - Each0781-542199e92c3e-3f08-4234-a6a4-11e198ea6a9b12013-03-03
0781-5421-92EA - Each0781-54213b1d7c82-89cb-40df-9423-975185dfda6e12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PIOGLITAZONE HYDROCHLORIDEACTIVE INGREDIENTJQT35NPK6CPIOGLITAZONE TABLET [SANDOZ INC]4
PIOGLITAZONEACTIVE MOIETYX4OV71U42SPIOGLITAZONE TABLET [SANDOZ INC]4
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LPIOGLITAZONE TABLET [SANDOZ INC]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPIOGLITAZONE TABLET [SANDOZ INC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPIOGLITAZONE TABLET [SANDOZ INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PIOGLITAZONE TABLET [SANDOZ INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-5421PIOGLITAZONE TABLET [SANDOZ INC]9Legacy NDC20191128_5e36173a-2b5f-4ed7-bf81-6e79d78df0c4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-5421-10007815421101000 TABLET in 1 BOTTLE (0781-5421-10) 1000 tablet2013-03-010000-00-00NoNoCurrent
0781-5421-310078154213130 TABLET in 1 BOTTLE (0781-5421-31) 30 tablet2013-03-010000-00-00NoNoCurrent
0781-5421-640078154216430 BLISTER PACK in 1 BOX, UNIT-DOSE (0781-5421-64) > 1 TABLET in 1 BLISTER PACK (0781-5421-06) 30 blister pack2013-03-010000-00-00NoNoCurrent
0781-5421-920078154219290 TABLET in 1 BOTTLE (0781-5421-92) 90 tablet2013-03-010000-00-00NoNoCurrent