Pioglitazone

Product NDC
68788-7511
11-digit product format
687887511
Labeler code
68788
Product ID
68788-7511_760ac087-6dc0-4027-b38a-4b4dfba2068f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, 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
Rxcui317573

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
68788-7511-1Pioglitazone100 in 1 BOTTLETABLET1007
68788-7511-3Pioglitazone30 in 1 BOTTLETABLET307
68788-7511-6Pioglitazone60 in 1 BOTTLETABLET607
68788-7511-9Pioglitazone90 in 1 BOTTLETABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7511PIOGLITAZONE TABLET [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 4 package rows20240731_060e3169-46a7-419d-9acc-05586cb2406b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7511-168788751101100 TABLET in 1 BOTTLE (68788-7511-1) 100 tablet2019-12-270000-00-00NoNoCurrent
68788-7511-36878875110330 TABLET in 1 BOTTLE (68788-7511-3) 30 tablet2019-12-270000-00-00NoNoCurrent
68788-7511-66878875110660 TABLET in 1 BOTTLE (68788-7511-6) 60 tablet2019-12-270000-00-00NoNoCurrent
68788-7511-96878875110990 TABLET in 1 BOTTLE (68788-7511-9) 90 tablet2019-12-270000-00-00NoNoCurrent