FDA.reportPublic FDA data

Pioglitazone

Product NDC
42291-960
11-digit product format
422910960
Labeler code
42291
Product ID
42291-960_48c10047-554b-2c47-e063-6394a90ac913
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA077210
Marketing category
ANDA
Marketing start
2024-09-17
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pioglitazone
Listing expiration
2027-12-31

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
3e9b6ece-066b-2ac3-28f7-5e13060e5934Product name220151109
0d79b284-47e8-e90c-f249-892b9b251003Product name120140508
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ac29cd77-922c-d25a-f8ad-66a8692935c5Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-960-30Pioglitazone30 in 1 BOTTLETABLET302
42291-960-90Pioglitazone90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-960-30EA - Each42291-960ceb1e6a9-7266-4da7-bdfd-265df48a931112024-10-04
42291-960-90EA - Each42291-9607433a400-0649-4b4a-9a9a-daad3541c8ae12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-960PIOGLITAZONE TABLET [AVKARE]1Current NDC, 2 package rows20240919_22569835-bc9f-7787-e063-6394a90a6232.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSN22569835-bc9f-7787-e063-6394a90a62322
312440pioglitazone 30 MG Oral TabletPSN22569835-bc9f-7787-e063-6394a90a62322
312441pioglitazone 45 MG Oral TabletPSN22569835-bc9f-7787-e063-6394a90a62322
317573pioglitazone 15 MG Oral TabletSCD22569835-bc9f-7787-e063-6394a90a62322
312440pioglitazone 30 MG Oral TabletSCD22569835-bc9f-7787-e063-6394a90a62322
312441pioglitazone 45 MG Oral TabletSCD22569835-bc9f-7787-e063-6394a90a62322
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY22569835-bc9f-7787-e063-6394a90a62322
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY22569835-bc9f-7787-e063-6394a90a62322
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY22569835-bc9f-7787-e063-6394a90a62322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42291-960-304229109603030 TABLET in 1 BOTTLE (42291-960-30) 30 tablet2024-09-17NoNoCurrent
42291-960-904229109609090 TABLET in 1 BOTTLE (42291-960-90) 90 tablet2024-09-17NoNoCurrent