Pioglitazone

Product NDC
70518-2129
11-digit product format
705182129
Labeler code
70518
Product ID
70518-2129_49a0f928-9f38-b108-e063-6394a90a2f00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA200268
Marketing category
ANDA
Marketing start
2019-06-04
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

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
70518-2129-0Pioglitazone90 in 1 BOTTLE, PLASTICTABLET9012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2129PIOGLITAZONE TABLET [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 1 package rows20250308_55f9b2d8-3e78-4e2f-bcf1-d00595078fa1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312440pioglitazone 30 MG Oral TabletPSN55f9b2d8-3e78-4e2f-bcf1-d00595078fa112
312440pioglitazone 30 MG Oral TabletSCD55f9b2d8-3e78-4e2f-bcf1-d00595078fa112
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY55f9b2d8-3e78-4e2f-bcf1-d00595078fa112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2129-07051821290090 TABLET in 1 BOTTLE, PLASTIC (70518-2129-0) 90 tablet2019-06-040000-00-00NoNoCurrent