FDA.reportPublic FDA data

PIOGLITAZONE

Product NDC
72189-105
11-digit product format
721890105
Labeler code
72189
Product ID
72189-105_2be8ed92-afbe-9ea7-e063-6294a90a5fcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PIOGLITAZONE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA200268
Marketing category
ANDA
Marketing start
2020-06-12
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
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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-105-90PIOGLITAZONE90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-105-90EA - Each72189-10555575413-fb94-4bdc-b435-4647a5679c7112020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-105PIOGLITAZONE TABLET [DIRECT RX]2Current NDC, Legacy NDC, 1 package rows20250119_a7e8d5a3-b0da-1d70-e053-2a95a90aa435.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312440pioglitazone 30 MG Oral TabletPSNa7e8d5a3-b0da-1d70-e053-2a95a90aa4352
312440pioglitazone 30 MG Oral TabletSCDa7e8d5a3-b0da-1d70-e053-2a95a90aa4352
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYa7e8d5a3-b0da-1d70-e053-2a95a90aa4352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-105-907218901059090 TABLET in 1 BOTTLE (72189-105-90) 90 tablet2020-06-120000-00-00NoNoCurrent