FDA.reportPublic FDA data

Pioglitazone

Product NDC
63304-313
11-digit product format
633040313
Labeler code
63304
Product ID
63304-313_a2a31eaf-b314-445c-a7dd-42a363a04092
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
Ranbaxy Pharmaceuticals Inc.
Application
NDA021073
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-08-17
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
E
Listing certified through
2018-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63304-313-052020-01-31C16284748780-19d75b9d0-bffe-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Pioglitazone Tablets safely and effectively. See full prescribing information for Pioglitazone Tablets. Pioglitazone Tablets for oral use Initial U.S. Approval: 1999
63304-313-302020-01-31C16284748780-19d75b9d0-bffe-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Pioglitazone Tablets safely and effectively. See full prescribing information for Pioglitazone Tablets. Pioglitazone Tablets for oral use Initial U.S. Approval: 1999
63304-313-902020-01-31C16284748780-19d75b9d0-bffe-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Pioglitazone Tablets safely and effectively. See full prescribing information for Pioglitazone Tablets. Pioglitazone Tablets for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-313-05Pioglitazone500 in 1 BOTTLETABLET5002
63304-313-30Pioglitazone30 in 1 BOTTLETABLET302
63304-313-90Pioglitazone90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-313-05EA - Each63304-31367a4dc8a-016b-49a8-9526-f3261fb5b72912013-02-13
63304-313-30EA - Each63304-31327c6b3d9-fcd1-41e8-9a0d-0a40049e3f4f12013-02-13
63304-313-90EA - Each63304-3131f831723-aa38-4731-b6dd-2bafb522d1f212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
pioglitazone hydrochlorideACTIVE INGREDIENTJQT35NPK6CPIOGLITAZONE TABLET [RANBAXY PHARMACEUTICALS INC.]2
pioglitazoneACTIVE MOIETYX4OV71U42SPIOGLITAZONE TABLET [RANBAXY PHARMACEUTICALS INC.]2
carboxymethylcellulose calciumINACTIVE INGREDIENTUTY7PDF93LPIOGLITAZONE TABLET [RANBAXY PHARMACEUTICALS INC.]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPIOGLITAZONE TABLET [RANBAXY PHARMACEUTICALS INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPIOGLITAZONE TABLET [RANBAXY PHARMACEUTICALS INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30PIOGLITAZONE TABLET [RANBAXY PHARMACEUTICALS INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-313PIOGLITAZONE TABLET [RANBAXY PHARMACEUTICALS INC.]2Legacy NDC, 3 package rows20130112_0478f0e7-87fb-4adb-ae9b-6624555ccbe4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSN0478f0e7-87fb-4adb-ae9b-6624555ccbe42
312440pioglitazone 30 MG Oral TabletPSN0478f0e7-87fb-4adb-ae9b-6624555ccbe42
312441pioglitazone 45 MG Oral TabletPSN0478f0e7-87fb-4adb-ae9b-6624555ccbe42
317573pioglitazone 15 MG Oral TabletSCD0478f0e7-87fb-4adb-ae9b-6624555ccbe42
312440pioglitazone 30 MG Oral TabletSCD0478f0e7-87fb-4adb-ae9b-6624555ccbe42
312441pioglitazone 45 MG Oral TabletSCD0478f0e7-87fb-4adb-ae9b-6624555ccbe42
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY0478f0e7-87fb-4adb-ae9b-6624555ccbe42
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY0478f0e7-87fb-4adb-ae9b-6624555ccbe42
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY0478f0e7-87fb-4adb-ae9b-6624555ccbe42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63304-313-0563304031305500 in 1 BOTTLEHistorical
63304-313-306330403133030 in 1 BOTTLEHistorical
63304-313-906330403139090 in 1 BOTTLEHistorical