FDA.reportPublic FDA data

Pioglitazone

Product NDC
68788-7514
11-digit product format
687887514
Labeler code
68788
Product ID
68788-7514_047b7d14-88f9-4a23-8843-0512b74cb5b2
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
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

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
68788-7514-1Pioglitazone100 in 1 BOTTLETABLET1006
68788-7514-3Pioglitazone30 in 1 BOTTLETABLET306
68788-7514-6Pioglitazone60 in 1 BOTTLETABLET606
68788-7514-9Pioglitazone90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7514-1EA - Each68788-7514765e0c3d-1db1-4002-b203-5ae8b869c28d12020-09-14
68788-7514-3EA - Each68788-7514ac6aa946-8e0b-4f80-beb9-8784e7990d9312020-09-14
68788-7514-6EA - Each68788-751481a4894f-6bf6-4b46-b4d2-669de84f8b8d12020-09-14
68788-7514-9EA - Each68788-751424810b29-d7c0-425e-a1be-8ffdfde229b012020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7514PIOGLITAZONE TABLET [PREFERRED PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 4 package rows20240731_164c444c-7c56-4482-9cbd-0e0f0ad30c44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7514-168788751401100 TABLET in 1 BOTTLE (68788-7514-1) 100 tablet2019-12-270000-00-00NoNoCurrent
68788-7514-36878875140330 TABLET in 1 BOTTLE (68788-7514-3) 30 tablet2019-12-270000-00-00NoNoCurrent
68788-7514-66878875140660 TABLET in 1 BOTTLE (68788-7514-6) 60 tablet2019-12-270000-00-00NoNoCurrent
68788-7514-96878875140990 TABLET in 1 BOTTLE (68788-7514-9) 90 tablet2019-12-270000-00-00NoNoCurrent