FDA.reportPublic FDA data

Pioglitazone

Product NDC
71335-1759
11-digit product format
713351759
Labeler code
71335
Product ID
71335-1759_043ced29-aa7d-48fb-9567-086f00d8ff36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200268
Marketing category
ANDA
Marketing start
2013-02-13
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
45 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 HYDROCHLORIDE45 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJQT35NPK6C
Rxcui312441

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
71335-1759-1Pioglitazone30 in 1 BOTTLETABLET30103
71335-1759-2Pioglitazone90 in 1 BOTTLETABLET90103
71335-1759-3Pioglitazone180 in 1 BOTTLETABLET180103

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312441pioglitazone 45 MG Oral TabletPSN466ef4c8-84d4-4ded-8505-a33f12adf31c103
312441pioglitazone 45 MG Oral TabletSCD466ef4c8-84d4-4ded-8505-a33f12adf31c103
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY466ef4c8-84d4-4ded-8505-a33f12adf31c103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1759-17133517590130 TABLET in 1 BOTTLE (71335-1759-1) 30 tablet2022-03-100000-00-00NoNoCurrent
71335-1759-27133517590290 TABLET in 1 BOTTLE (71335-1759-2) 90 tablet2022-03-100000-00-00NoNoCurrent
71335-1759-371335175903180 TABLET in 1 BOTTLE (71335-1759-3) 180 tablet2022-03-10NoNoHistorical