FDA.reportPublic FDA data

Alogliptin and Pioglitazone

Product NDC
45802-260
11-digit product format
458020260
Labeler code
45802
Product ID
45802-260_11c471e0-6c64-4f13-b6ed-d2c80bc89f20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alogliptin Benzoate and Pioglitazone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
NDA022426
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-04-08
Substance
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
Active strength
12.5; 30 mg/1; mg/1
Pharmacologic classes
Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA], 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
Alogliptin and Pioglitazone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALOGLIPTIN BENZOATE12.5 mg/1
PIOGLITAZONE HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJQT35NPK6C, EEN99869SC
Rxcui1368410, 1368424, 1368431, 1368438

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
36db81cb-9c11-39e1-6a1a-715fc2caa47cProduct name120140508
7611093e-8875-33d4-9e3c-f48c7e3af1e8Product name120140508
ac29cd77-922c-d25a-f8ad-66a8692935c5Product name120140508
ce63c1f8-ba50-8a17-9290-94522d75daffProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-260-65Alogliptin and Pioglitazone30 in 1 BOTTLETABLET, FILM COATED3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-260-65EA - Each45802-26046e8d785-3ed0-4696-a385-dddf6811060f12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-260ALOGLIPTIN AND PIOGLITAZONE (ALOGLIPTIN BENZOATE AND PIOGLITAZONE HYDROCHLORIDE) TABLET, FILM COATED [PADAGIS ISRAEL PHARMACEUTICALS LTD]10Current NDC, Legacy NDC, 1 package rows20240915_642b1e90-701e-42f2-bac6-a4918738e2c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1368410alogliptin 12.5 MG / pioglitazone 30 MG Oral TabletPSN642b1e90-701e-42f2-bac6-a4918738e2c911
1368424alogliptin 25 MG / pioglitazone 15 MG Oral TabletPSN642b1e90-701e-42f2-bac6-a4918738e2c911
1368431alogliptin 25 MG / pioglitazone 30 MG Oral TabletPSN642b1e90-701e-42f2-bac6-a4918738e2c911
1368438alogliptin 25 MG / pioglitazone 45 MG Oral TabletPSN642b1e90-701e-42f2-bac6-a4918738e2c911
1368410alogliptin 12.5 MG / pioglitazone 30 MG Oral TabletSCD642b1e90-701e-42f2-bac6-a4918738e2c911
1368424alogliptin 25 MG / pioglitazone 15 MG Oral TabletSCD642b1e90-701e-42f2-bac6-a4918738e2c911
1368431alogliptin 25 MG / pioglitazone 30 MG Oral TabletSCD642b1e90-701e-42f2-bac6-a4918738e2c911
1368438alogliptin 25 MG / pioglitazone 45 MG Oral TabletSCD642b1e90-701e-42f2-bac6-a4918738e2c911
1368410alogliptin 12.5 MG (as alogliptin benzoate 17 MG) / pioglitazone 30 MG (as pioglitazone hydrochloride 33.06 MG) Oral TabletSY642b1e90-701e-42f2-bac6-a4918738e2c911
1368424alogliptin 25 MG (as alogliptin benzoate 34 MG) / pioglitazone 15 MG (as pioglitazone hydrochloride 16.53 MG) Oral TabletSY642b1e90-701e-42f2-bac6-a4918738e2c911
1368431alogliptin 25 MG (as alogliptin benzoate 34 MG) / pioglitazone 30 MG (as pioglitazone hydrochloride 33.06 MG) Oral TabletSY642b1e90-701e-42f2-bac6-a4918738e2c911
1368438alogliptin 25 MG (as alogliptin benzoate 34 MG) / pioglitazone 45 MG (as pioglitazone hydrochloride 49.59 MG) Oral TabletSY642b1e90-701e-42f2-bac6-a4918738e2c911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45802-260-654580202606530 TABLET, FILM COATED in 1 BOTTLE (45802-260-65) 2016-04-080000-00-00NoNoCurrent