FDA.reportPublic FDA data

Pioglitazone

Product NDC
57237-220
11-digit product format
572370220
Labeler code
57237
Product ID
57237-220_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
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, 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
57237-220-05Pioglitazone500 in 1 BOTTLETABLET50011
57237-220-30Pioglitazone30 in 1 BOTTLETABLET3011
57237-220-90Pioglitazone90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-220-05EA - Each57237-220f2825578-380a-4109-b972-a8aa5142f94912017-10-13
57237-220-30EA - Each57237-22047efb552-a656-4c29-a0ed-0af29cbd331a12017-10-13
57237-220-90EA - Each57237-22025ee6c02-76a4-4b29-b35f-ddc99c5e18b412019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-220PIOGLITAZONE 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
312440pioglitazone 30 MG Oral TabletPSN55f9b2d8-3e78-4e2f-bcf1-d00595078fa112
312440pioglitazone 30 MG Oral TabletSCD55f9b2d8-3e78-4e2f-bcf1-d00595078fa112
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY55f9b2d8-3e78-4e2f-bcf1-d00595078fa112
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
312440pioglitazone 30 MG Oral TabletPSN6397fb4c-081b-4abd-ab4b-0a3fbf99e6637
312440pioglitazone 30 MG Oral TabletSCD6397fb4c-081b-4abd-ab4b-0a3fbf99e6637
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY6397fb4c-081b-4abd-ab4b-0a3fbf99e6637
312440pioglitazone 30 MG Oral TabletPSN164c444c-7c56-4482-9cbd-0e0f0ad30c446
312440pioglitazone 30 MG Oral TabletSCD164c444c-7c56-4482-9cbd-0e0f0ad30c446
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY164c444c-7c56-4482-9cbd-0e0f0ad30c446
317573pioglitazone 15 MG Oral TabletPSN72b46a1e-d9ea-4a47-95ef-5eae96ef1e7f4
312440pioglitazone 30 MG Oral TabletPSN72b46a1e-d9ea-4a47-95ef-5eae96ef1e7f4
312440pioglitazone 30 MG Oral TabletPSN8d5ac747-991f-30e4-e053-2a95a90a47804
317573pioglitazone 15 MG Oral TabletSCD72b46a1e-d9ea-4a47-95ef-5eae96ef1e7f4
312440pioglitazone 30 MG Oral TabletSCD72b46a1e-d9ea-4a47-95ef-5eae96ef1e7f4
312440pioglitazone 30 MG Oral TabletSCD8d5ac747-991f-30e4-e053-2a95a90a47804
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY72b46a1e-d9ea-4a47-95ef-5eae96ef1e7f4
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY8d5ac747-991f-30e4-e053-2a95a90a47804
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY72b46a1e-d9ea-4a47-95ef-5eae96ef1e7f4
312440pioglitazone 30 MG Oral TabletPSNa1112e4b-e9d5-13c3-e053-2995a90a6d0a3
312440pioglitazone 30 MG Oral TabletSCDa1112e4b-e9d5-13c3-e053-2995a90a6d0a3
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYa1112e4b-e9d5-13c3-e053-2995a90a6d0a3
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
312440pioglitazone 30 MG Oral TabletPSNf725cdaf-fc7a-40d6-ba64-1dccd1b25d7a1
312440pioglitazone 30 MG Oral TabletSCDf725cdaf-fc7a-40d6-ba64-1dccd1b25d7a1
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSYf725cdaf-fc7a-40d6-ba64-1dccd1b25d7a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-220-0557237022005500 TABLET in 1 BOTTLE (57237-220-05) 500 tablet2013-02-130000-00-00NoNoCurrent
57237-220-305723702203030 TABLET in 1 BOTTLE (57237-220-30) 30 tablet2013-02-130000-00-00NoNoCurrent
57237-220-905723702209090 TABLET in 1 BOTTLE (57237-220-90) 90 tablet2019-06-120000-00-00NoNoCurrent