FDA.reportPublic FDA data

Pioglitazone

Product NDC
71335-1333
11-digit product format
713351333
Labeler code
71335
Product ID
71335-1333_3a8f06d2-3943-48c9-b5ef-9fd6be640a82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077210
Marketing category
ANDA
Marketing start
2015-02-04
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
30 mg/1
Pharmacologic classes
Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA], Peroxisome Proliferator-activated Receptor gamma Agonists [MoA], Thiazolidinedione [EPC], Thiazolidinediones [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pioglitazone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIOGLITAZONE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJQT35NPK6C
Rxcui312440

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
71335-1333-12024-01-30C16284748780-11030e365-43f0-111a-e063-dadaa90a10e2These 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
71335-1333-22024-01-30C16284748780-11030e365-43f0-111a-e063-dadaa90a10e2These 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
71335-1333-32024-01-30C16284748780-11030e365-43f0-111a-e063-dadaa90a10e2These 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
71335-1333-42024-01-30C16284748780-11030e365-43f0-111a-e063-dadaa90a10e2These 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
71335-1333-1Pioglitazone30 in 1 BOTTLETABLET30101
71335-1333-2Pioglitazone60 in 1 BOTTLETABLET60101
71335-1333-3Pioglitazone90 in 1 BOTTLETABLET90101
71335-1333-4Pioglitazone180 in 1 BOTTLETABLET180101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1333-1EA - Each71335-13332676b4ea-c632-4e5c-b949-1a1f13edf15312021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1333PIOGLITAZONE TABLET [BRYANT RANCH PREPACK]100Current NDC, Legacy NDC, 4 package rows20220211_fbdaaa34-06c4-49af-85b4-91a85922b30b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312440pioglitazone 30 MG Oral TabletPSNfbdaaa34-06c4-49af-85b4-91a85922b30b101
312440pioglitazone 30 MG Oral TabletSCDfbdaaa34-06c4-49af-85b4-91a85922b30b101
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYfbdaaa34-06c4-49af-85b4-91a85922b30b101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1333-17133513330130 TABLET in 1 BOTTLE (71335-1333-1) 30 tablet2022-02-090000-00-00NoNoCurrent
71335-1333-27133513330260 TABLET in 1 BOTTLE (71335-1333-2) 60 tablet2022-02-090000-00-00NoNoCurrent
71335-1333-37133513330390 TABLET in 1 BOTTLE (71335-1333-3) 90 tablet2022-02-090000-00-00NoNoCurrent
71335-1333-471335133304180 TABLET in 1 BOTTLE (71335-1333-4) 180 tablet2022-02-090000-00-00NoNoCurrent