Pioglitazone

Product NDC
16714-645
11-digit product format
167140645
Labeler code
16714
Product ID
16714-645_099c78c5-8f25-4dc6-a713-b934d0067438
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pioglitazone
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA202467
Marketing category
ANDA
Marketing start
2022-08-18
Substance
PIOGLITAZONE HYDROCHLORIDE
Active strength
15 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 HYDROCHLORIDE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJQT35NPK6C
Rxcui312440, 312441, 317573

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
16714-645-01Pioglitazone30 in 1 BOTTLETABLET302
16714-645-02Pioglitazone90 in 1 BOTTLETABLET902
16714-645-03Pioglitazone500 in 1 BOTTLETABLET5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-645-01EA - Each16714-645651fed06-33d8-4a86-b186-d3c3e06f55d412023-01-09
16714-645-02EA - Each16714-64517e23ccb-25fb-49fc-a8b7-ce47a5f39aee12023-01-09
16714-645-03EA - Each16714-645b3036a2f-0507-4297-84fd-33b7e65461ca12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-645PIOGLITAZONE TABLET [NORTHSTAR RXLLC]2Current NDC, Legacy NDC, 3 package rows20220909_692e662a-3b31-42c3-a075-42abe44c74db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317573pioglitazone 15 MG Oral TabletPSN692e662a-3b31-42c3-a075-42abe44c74db2
312440pioglitazone 30 MG Oral TabletPSN692e662a-3b31-42c3-a075-42abe44c74db2
312441pioglitazone 45 MG Oral TabletPSN692e662a-3b31-42c3-a075-42abe44c74db2
317573pioglitazone 15 MG Oral TabletSCD692e662a-3b31-42c3-a075-42abe44c74db2
312440pioglitazone 30 MG Oral TabletSCD692e662a-3b31-42c3-a075-42abe44c74db2
312441pioglitazone 45 MG Oral TabletSCD692e662a-3b31-42c3-a075-42abe44c74db2
312441pioglitazone (as pioglitazone HCl) 45 MG Oral TabletSY692e662a-3b31-42c3-a075-42abe44c74db2
317573pioglitazone (as pioglitazone hydrochloride) 15 MG Oral TabletSY692e662a-3b31-42c3-a075-42abe44c74db2
312440pioglitazone (as pioglitazone hydrochloride) 30 MG Oral TabletSY692e662a-3b31-42c3-a075-42abe44c74db2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-645-011671406450130 TABLET in 1 BOTTLE (16714-645-01) 30 tablet2022-08-180000-00-00NoNoCurrent
16714-645-021671406450290 TABLET in 1 BOTTLE (16714-645-02) 90 tablet2022-08-180000-00-00NoNoCurrent
16714-645-0316714064503500 TABLET in 1 BOTTLE (16714-645-03) 500 tablet2022-08-180000-00-00NoNoCurrent