PIOGLITAZONE HYDROCHLORIDE

Product NDC
70518-4519
11-digit product format
705184519
Labeler code
70518
Product ID
70518-4519_4390d6f4-41fe-9b18-e063-6394a90a8031
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pioglitazone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA200268
Marketing category
ANDA
Marketing start
2025-11-14
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PIOGLITAZONE HYDROCHLORIDE
Listing expiration
2026-12-31

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
70518-4519-0PIOGLITAZONE HYDROCHLORIDE90 in 1 BOTTLE, PLASTICTABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312441pioglitazone 45 MG Oral TabletPSN04577c39-a9c0-4c66-a775-4c79e2c3dea51
312441pioglitazone 45 MG Oral TabletSCD04577c39-a9c0-4c66-a775-4c79e2c3dea51
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY04577c39-a9c0-4c66-a775-4c79e2c3dea51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4519-07051845190090 TABLET in 1 BOTTLE, PLASTIC (70518-4519-0) 90 tablet2025-11-14NoNoCurrent