FDA.reportPublic FDA data

Pioglitazone

Product NDC
50090-6412
11-digit product format
500906412
Labeler code
50090
Product ID
50090-6412_f4fbafda-1f75-45ab-90cc-2ab67a9ae973
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
45 mg/1
Pharmacologic classes
PPAR alpha [CS], PPAR gamma [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator Receptor gamma Agonist [EPC], Peroxisome Proliferator-activated Receptor Activity [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 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
50090-6412-0Pioglitazone30 in 1 BOTTLETABLET301
50090-6412-1Pioglitazone90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6412-0EA - Each50090-6412a46af0f3-f076-4f99-9af4-3e1f136c2b3012023-05-05
50090-6412-1EA - Each50090-6412ec59576c-5989-4965-939c-d768303e878812023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6412PIOGLITAZONE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20230406_475c4f39-dd2a-48f9-a07c-9344bbda58a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312441pioglitazone 45 MG Oral TabletPSN475c4f39-dd2a-48f9-a07c-9344bbda58a91
312441pioglitazone 45 MG Oral TabletSCD475c4f39-dd2a-48f9-a07c-9344bbda58a91
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY475c4f39-dd2a-48f9-a07c-9344bbda58a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6412-05009064120030 TABLET in 1 BOTTLE (50090-6412-0) 30 tablet2023-03-28NoNoHistorical
50090-6412-15009064120190 TABLET in 1 BOTTLE (50090-6412-1) 90 tablet2023-03-28NoNoHistorical