Pioglitazone

Product NDC
66116-504
11-digit product format
661160504
Labeler code
66116
Product ID
66116-504_a3ae5cba-f495-4593-b8fc-5ada34790745
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
MedVantx, Inc.
Application
NDA021073
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-08-17
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e11f0f31-8914-938f-521e-037b6de27c13Product name520210621
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
ac29cd77-922c-d25a-f8ad-66a8692935c5Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-504-30Pioglitazone30 in 1 BOTTLETABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
pioglitazone hydrochlorideACTIVE INGREDIENTJQT35NPK6CPIOGLITAZONE TABLET [MEDVANTX, INC.]1
pioglitazoneACTIVE MOIETYX4OV71U42SPIOGLITAZONE TABLET [MEDVANTX, INC.]1
carboxymethylcellulose calciumINACTIVE INGREDIENTUTY7PDF93LPIOGLITAZONE TABLET [MEDVANTX, INC.]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPIOGLITAZONE TABLET [MEDVANTX, INC.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPIOGLITAZONE TABLET [MEDVANTX, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30PIOGLITAZONE TABLET [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-504PIOGLITAZONE TABLET [MEDVANTX, INC.]1Legacy NDC, 1 package rows20130821_a3ae5cba-f495-4593-b8fc-5ada34790745.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSNa3ae5cba-f495-4593-b8fc-5ada347907451
317573pioglitazone 15 MG Oral TabletSCDa3ae5cba-f495-4593-b8fc-5ada347907451
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSYa3ae5cba-f495-4593-b8fc-5ada347907451

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66116-504-306611605043030 in 1 BOTTLEHistorical