Pioglitazone

Product NDC
0781-5422
11-digit product format
007815422
Labeler code
0781
Product ID
0781-5422_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
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
0781-5422-10EA - Each0781-5422c8f73a0b-6cc7-435b-a173-b5b5da13361012013-03-03
0781-5422-31EA - Each0781-5422f0257dae-38c8-46d5-96a9-647982370d4812013-03-03
0781-5422-92EA - Each0781-54228b90c154-39ad-48be-8230-2b9190f33f7212013-03-03

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
0781-5422PIOGLITAZONE 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
0781-5422-10007815422101000 TABLET in 1 BOTTLE (0781-5422-10) 1000 tablet2013-03-010000-00-00NoNoCurrent
0781-5422-310078154223130 TABLET in 1 BOTTLE (0781-5422-31) 30 tablet2013-03-010000-00-00NoNoCurrent
0781-5422-640078154226430 BLISTER PACK in 1 BOX, UNIT-DOSE (0781-5422-64) > 1 TABLET in 1 BLISTER PACK (0781-5422-06) 30 blister pack2013-03-010000-00-00NoNoCurrent
0781-5422-920078154229290 TABLET in 1 BOTTLE (0781-5422-92) 90 tablet2013-03-010000-00-00NoNoCurrent