FDA.reportPublic FDA data

Pioglitazone

Product NDC
50090-6874
11-digit product format
500906874
Labeler code
50090
Product ID
50090-6874_3b1dc082-75a6-412f-8d58-e79677e4a9c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202467
Marketing category
ANDA
Marketing start
2022-08-18
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
50090-6874-0Pioglitazone90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6874-0EA - Each50090-687406f2cc4a-f99e-4b51-81df-aa4540155df112024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6874PIOGLITAZONE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20231207_9fe57786-5c7d-4b11-8fb4-de341e2e5128.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312440pioglitazone 30 MG Oral TabletPSN9fe57786-5c7d-4b11-8fb4-de341e2e51281
312440pioglitazone 30 MG Oral TabletSCD9fe57786-5c7d-4b11-8fb4-de341e2e51281
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY9fe57786-5c7d-4b11-8fb4-de341e2e51281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6874-05009068740090 TABLET in 1 BOTTLE (50090-6874-0) 90 tablet2023-12-04NoNoCurrent