Pioglitazone

Product NDC
53002-2756
11-digit product format
530022756
Labeler code
53002
Product ID
53002-2756_e53aa583-5db1-4710-8805-f3ae828038b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA077210
Marketing category
ANDA
Marketing start
2015-02-04
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e11f0f31-8914-938f-521e-037b6de27c13Product name520210621
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ac29cd77-922c-d25a-f8ad-66a8692935c5Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-2756-32025-01-30C16284748780-1f386c649-fb8a-0266-e053-dadaa90a7c1aThese 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
53002-2756-92025-01-30C16284748780-1f386c649-fb8a-0266-e053-dadaa90a7c1aThese 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
53002-2756-32023-06-07C16284748780-1f386c649-fb8a-0266-e053-dadaa90a7c1aThese 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
53002-2756-92023-06-07C16284748780-1f386c649-fb8a-0266-e053-dadaa90a7c1aThese 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
53002-2756-32023-01-30C16284748780-1f386c649-fb8a-0266-e053-dadaa90a7c1aThese 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
53002-2756-92023-01-30C16284748780-1f386c649-fb8a-0266-e053-dadaa90a7c1aThese 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
53002-2756-3Pioglitazone30 in 1 BOTTLETABLET303
53002-2756-9Pioglitazone90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2756PIOGLITAZONE TABLET [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 2 package rows20230609_0b1e935f-742a-4879-8a2c-a11e75f7071e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312440pioglitazone 30 MG Oral TabletPSN0b1e935f-742a-4879-8a2c-a11e75f7071e3
312440pioglitazone 30 MG Oral TabletSCD0b1e935f-742a-4879-8a2c-a11e75f7071e3
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY0b1e935f-742a-4879-8a2c-a11e75f7071e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2756-35300227560330 TABLET in 1 BOTTLE (53002-2756-3) 30 tablet2020-01-010000-00-00NoNoCurrent
53002-2756-95300227560990 TABLET in 1 BOTTLE (53002-2756-9) 90 tablet2020-01-010000-00-00NoNoCurrent