Pioglitazone Hydrochloride

Product NDC
66336-857
11-digit product format
663360857
Labeler code
66336
Product ID
66336-857_6a51f874-89d9-4437-a8a8-462bb3a08801
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pioglitazone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Dispensing Solutions, Inc.
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
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
66336-857-30Pioglitazone Hydrochloride30 in 1 BOTTLETABLET303
66336-857-90Pioglitazone Hydrochloride90 in 1 BOTTLETABLET903

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
pioglitazone hydrochlorideACTIVE INGREDIENTJQT35NPK6CPIOGLITAZONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
pioglitazoneACTIVE MOIETYX4OV71U42SPIOGLITAZONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LPIOGLITAZONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPIOGLITAZONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPIOGLITAZONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PIOGLITAZONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-857PIOGLITAZONE HYDROCHLORIDE TABLET [DISPENSING SOLUTIONS, INC.]3Legacy NDC, 2 package rows20130715_71b48b31-5b50-4c11-91a8-d3a8cc8e6bf8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSN71b48b31-5b50-4c11-91a8-d3a8cc8e6bf83
317573pioglitazone 15 MG Oral TabletSCD71b48b31-5b50-4c11-91a8-d3a8cc8e6bf83
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY71b48b31-5b50-4c11-91a8-d3a8cc8e6bf83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-857-306633608573030 in 1 BOTTLEHistorical
66336-857-906633608579090 in 1 BOTTLEHistorical