FDA.reportPublic FDA data

Pioglitazone

Product NDC
57237-219
11-digit product format
572370219
Labeler code
57237
Product ID
57237-219_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
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
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
57237-219-05Pioglitazone500 in 1 BOTTLETABLET50011
57237-219-30Pioglitazone30 in 1 BOTTLETABLET3011
57237-219-90Pioglitazone90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-219-05EA - Each57237-219754a60c6-560b-48de-91ea-4345e876a42912017-10-13
57237-219-30EA - Each57237-2198ec8a7db-d22f-4db8-9585-9b6c2d18f46712017-10-13
57237-219-90EA - Each57237-2194e50941b-2002-4380-87bd-3d5cb0683c3c12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-219PIOGLITAZONE 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
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
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
317573pioglitazone 15 MG Oral TabletPSN3a9f6777-9b4f-482a-aa4e-4900f9d35b8e9
317573pioglitazone 15 MG Oral TabletSCD3a9f6777-9b4f-482a-aa4e-4900f9d35b8e9
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY3a9f6777-9b4f-482a-aa4e-4900f9d35b8e9
317573pioglitazone 15 MG Oral TabletPSN060e3169-46a7-419d-9acc-05586cb2406b7
317573pioglitazone 15 MG Oral TabletSCD060e3169-46a7-419d-9acc-05586cb2406b7
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY060e3169-46a7-419d-9acc-05586cb2406b7
317573pioglitazone 15 MG Oral TabletPSN5f844e44-0f0d-4b28-9d34-b97780e1c6ec5
317573pioglitazone 15 MG Oral TabletSCD5f844e44-0f0d-4b28-9d34-b97780e1c6ec5
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY5f844e44-0f0d-4b28-9d34-b97780e1c6ec5
317573pioglitazone 15 MG Oral TabletPSN72b46a1e-d9ea-4a47-95ef-5eae96ef1e7f4
312440pioglitazone 30 MG Oral TabletPSN72b46a1e-d9ea-4a47-95ef-5eae96ef1e7f4
317573pioglitazone 15 MG Oral TabletSCD72b46a1e-d9ea-4a47-95ef-5eae96ef1e7f4
312440pioglitazone 30 MG Oral TabletSCD72b46a1e-d9ea-4a47-95ef-5eae96ef1e7f4
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY72b46a1e-d9ea-4a47-95ef-5eae96ef1e7f4
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY72b46a1e-d9ea-4a47-95ef-5eae96ef1e7f4
317573pioglitazone 15 MG Oral TabletPSNa0846e3e-68b2-fd55-e053-2995a90a673e2
317573pioglitazone 15 MG Oral TabletSCDa0846e3e-68b2-fd55-e053-2995a90a673e2
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSYa0846e3e-68b2-fd55-e053-2995a90a673e2
317573pioglitazone 15 MG Oral TabletPSNee00c2b1-e777-2e85-e053-2995a90aa68c1
317573pioglitazone 15 MG Oral TabletPSNf434ba0d-13f3-42ae-a2d5-cddb93fde1e81
317573pioglitazone 15 MG Oral TabletPSN26bab958-7d2c-d331-e063-6394a90a05fb1
317573pioglitazone 15 MG Oral TabletSCDee00c2b1-e777-2e85-e053-2995a90aa68c1
317573pioglitazone 15 MG Oral TabletSCDf434ba0d-13f3-42ae-a2d5-cddb93fde1e81
317573pioglitazone 15 MG Oral TabletSCD26bab958-7d2c-d331-e063-6394a90a05fb1
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSYee00c2b1-e777-2e85-e053-2995a90aa68c1
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSYf434ba0d-13f3-42ae-a2d5-cddb93fde1e81
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY26bab958-7d2c-d331-e063-6394a90a05fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-219-0557237021905500 TABLET in 1 BOTTLE (57237-219-05) 500 tablet2013-02-130000-00-00NoNoCurrent
57237-219-305723702193030 TABLET in 1 BOTTLE (57237-219-30) 30 tablet2013-02-130000-00-00NoNoCurrent
57237-219-905723702199090 TABLET in 1 BOTTLE (57237-219-90) 90 tablet2019-06-120000-00-00NoNoCurrent