FDA.reportPublic FDA data

PIOGLITAZONE HYDROCHLORIDE

Product NDC
82009-103
11-digit product format
820090103
Labeler code
82009
Product ID
82009-103_c628bc60-920f-4d54-b41e-820aaccff112
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pioglitazone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
QUALLENT PHARMACEUTICALS HEALTH LLC
Application
ANDA200268
Marketing category
ANDA
Marketing start
2023-08-01
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 HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIOGLITAZONE HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJQT35NPK6C
Rxcui312440, 312441, 317573

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
82009-103-05PIOGLITAZONE HYDROCHLORIDE500 in 1 BOTTLETABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-103PIOGLITAZONE HYDROCHLORIDE TABLET [QUALLENT PHARMACEUTICALS HEALTH LLC]2Current NDC, 1 package rows20240613_0331400c-b163-4856-bfb0-965470247cb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSN0331400c-b163-4856-bfb0-965470247cb33
312440pioglitazone 30 MG Oral TabletPSN0331400c-b163-4856-bfb0-965470247cb33
312441pioglitazone 45 MG Oral TabletPSN0331400c-b163-4856-bfb0-965470247cb33
317573pioglitazone 15 MG Oral TabletSCD0331400c-b163-4856-bfb0-965470247cb33
312440pioglitazone 30 MG Oral TabletSCD0331400c-b163-4856-bfb0-965470247cb33
312441pioglitazone 45 MG Oral TabletSCD0331400c-b163-4856-bfb0-965470247cb33
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY0331400c-b163-4856-bfb0-965470247cb33
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY0331400c-b163-4856-bfb0-965470247cb33
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY0331400c-b163-4856-bfb0-965470247cb33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82009-103-0582009010305500 TABLET in 1 BOTTLE (82009-103-05) 500 tablet2023-08-01NoNoCurrent