FDA.reportPublic FDA data

Pioglitazone

Product NDC
71335-1343
11-digit product format
713351343
Labeler code
71335
Product ID
71335-1343_1c2f9d07-452b-43cd-8047-2f70b3e377fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200268
Marketing category
ANDA
Marketing start
2013-02-13
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
15 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pioglitazone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIOGLITAZONE HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJQT35NPK6C
Rxcui317573

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1343-1Pioglitazone30 in 1 BOTTLETABLET30103
71335-1343-2Pioglitazone90 in 1 BOTTLETABLET90103
71335-1343-3Pioglitazone60 in 1 BOTTLETABLET60103
71335-1343-4Pioglitazone120 in 1 BOTTLETABLET120103
71335-1343-5Pioglitazone180 in 1 BOTTLETABLET180103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1343PIOGLITAZONE TABLET [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 5 package rows20241225_f6cad01e-cd65-4c8d-9e49-399404f22005.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSNf6cad01e-cd65-4c8d-9e49-399404f22005103
317573pioglitazone 15 MG Oral TabletSCDf6cad01e-cd65-4c8d-9e49-399404f22005103
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSYf6cad01e-cd65-4c8d-9e49-399404f22005103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1343-17133513430130 TABLET in 1 BOTTLE (71335-1343-1) 30 tablet2019-09-110000-00-00NoNoCurrent
71335-1343-27133513430290 TABLET in 1 BOTTLE (71335-1343-2) 90 tablet2023-05-150000-00-00NoNoCurrent
71335-1343-37133513430360 TABLET in 1 BOTTLE (71335-1343-3) 60 tablet2024-12-100000-00-00NoNoCurrent
71335-1343-471335134304120 TABLET in 1 BOTTLE (71335-1343-4) 120 tablet2024-12-100000-00-00NoNoCurrent
71335-1343-571335134305180 TABLET in 1 BOTTLE (71335-1343-5) 180 tablet2024-12-10NoNoHistorical