FDA.reportPublic FDA data

PIOGLITAZONE HYDROCHLORIDE

Product NDC
50090-6386
11-digit product format
500906386
Labeler code
50090
Product ID
50090-6386_8e2928fe-c7c2-421b-94f5-63480f2ad156
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pioglitazone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA200268
Marketing category
ANDA
Marketing start
2013-02-13
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
15 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 HYDROCHLORIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIOGLITAZONE HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJQT35NPK6C
Rxcui317573

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
50090-6386-0PIOGLITAZONE HYDROCHLORIDE30 in 1 BOTTLETABLET305
50090-6386-1PIOGLITAZONE HYDROCHLORIDE90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6386-0EA - Each50090-6386d9fcc983-5717-4bf8-8cb9-8eafb4537e4912023-04-07
50090-6386-1EA - Each50090-638621e03dd0-7974-4514-9495-d1c4b87b96a312023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6386PIOGLITAZONE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, 2 package rows20230321_6cd7c8b7-f5d4-423b-ae9f-86541869d8cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSN6cd7c8b7-f5d4-423b-ae9f-86541869d8cf5
317573pioglitazone 15 MG Oral TabletSCD6cd7c8b7-f5d4-423b-ae9f-86541869d8cf5
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY6cd7c8b7-f5d4-423b-ae9f-86541869d8cf5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6386-05009063860030 TABLET in 1 BOTTLE (50090-6386-0) 30 tablet2023-03-07NoNoCurrent
50090-6386-15009063860190 TABLET in 1 BOTTLE (50090-6386-1) 90 tablet2023-03-17NoNoCurrent