FDA.reportPublic FDA data

Pioglitazone

Product NDC
57237-221
11-digit product format
572370221
Labeler code
57237
Product ID
57237-221_f3308268-8023-434e-8caf-734ca298b98e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA200268
Marketing category
ANDA
Marketing start
2013-02-13
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
45 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 HYDROCHLORIDE45 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
57237-221-05Pioglitazone500 in 1 BOTTLETABLET50011
57237-221-30Pioglitazone30 in 1 BOTTLETABLET3011
57237-221-90Pioglitazone90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-221-05EA - Each57237-22196c0aac2-05d0-411e-b96c-55bca803774212017-10-13
57237-221-30EA - Each57237-221172c86dc-847a-43ea-92b7-1b4032ec6de012017-10-13
57237-221-90EA - Each57237-22106a1b99c-b638-4968-8a84-527e7644baab12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-221PIOGLITAZONE TABLET [RISING PHARMA HOLDINGS, INC.]11Current NDC, Legacy NDC, 3 package rows20250523_4483b1c6-7095-4a63-8128-ac2d91e11040.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312441pioglitazone 45 MG Oral TabletPSN466ef4c8-84d4-4ded-8505-a33f12adf31c103
312441pioglitazone 45 MG Oral TabletSCD466ef4c8-84d4-4ded-8505-a33f12adf31c103
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY466ef4c8-84d4-4ded-8505-a33f12adf31c103
317573pioglitazone 15 MG Oral TabletPSN4483b1c6-7095-4a63-8128-ac2d91e1104011
312440pioglitazone 30 MG Oral TabletPSN4483b1c6-7095-4a63-8128-ac2d91e1104011
312441pioglitazone 45 MG Oral TabletPSN4483b1c6-7095-4a63-8128-ac2d91e1104011
317573pioglitazone 15 MG Oral TabletSCD4483b1c6-7095-4a63-8128-ac2d91e1104011
312440pioglitazone 30 MG Oral TabletSCD4483b1c6-7095-4a63-8128-ac2d91e1104011
312441pioglitazone 45 MG Oral TabletSCD4483b1c6-7095-4a63-8128-ac2d91e1104011
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY4483b1c6-7095-4a63-8128-ac2d91e1104011
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY4483b1c6-7095-4a63-8128-ac2d91e1104011
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY4483b1c6-7095-4a63-8128-ac2d91e1104011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-221-0557237022105500 TABLET in 1 BOTTLE (57237-221-05) 500 tablet2013-02-130000-00-00NoNoCurrent
57237-221-305723702213030 TABLET in 1 BOTTLE (57237-221-30) 30 tablet2013-02-130000-00-00NoNoCurrent
57237-221-905723702219090 TABLET in 1 BOTTLE (57237-221-90) 90 tablet2013-02-130000-00-00NoNoCurrent