NDC 64764-124

OSENI

Alogliptin And Pioglitazone

OSENI is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Alogliptin Benzoate; Pioglitazone Hydrochloride.

Product ID64764-124_49bce7dd-24dc-4a5c-b7d9-68446011e478
NDC64764-124
Product TypeHuman Prescription Drug
Proprietary NameOSENI
Generic NameAlogliptin And Pioglitazone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2013-01-25
Marketing CategoryNDA / NDA
Application NumberNDA022426
Labeler NameTakeda Pharmaceuticals America, Inc.
Substance NameALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
Active Ingredient Strength13 mg/1; mg/1
Pharm ClassesDipeptidyl Peptidase 4 Inhibitors [MoA],Dipeptidyl Peptidase 4 Inhibitor [EPC],Peroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 64764-124-03

30 TABLET, FILM COATED in 1 BOTTLE (64764-124-03)
Marketing Start Date2013-01-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64764-124-04 [64764012404]

OSENI TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022426
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-25

NDC 64764-124-03 [64764012403]

OSENI TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022426
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-01-25

NDC 64764-124-05 [64764012405]

OSENI TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022426
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-25

NDC 64764-124-06 [64764012406]

OSENI TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA022426
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-01-25
Marketing End Date2018-01-05

Drug Details

Active Ingredients

IngredientStrength
ALOGLIPTIN BENZOATE12.5 mg/1

OpenFDA Data

SPL SET ID:4c619ed9-fe3e-4158-9938-80c6c3493d55
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1368423
  • 1368430
  • 1368409
  • 1368424
  • 1368438
  • 1368410
  • 1368437
  • 1368416
  • 1368417
  • 1368403
  • 1368431
  • 1368444
  • UPC Code
  • 0364764123031
  • 0364764254032
  • 0364764251031
  • 0364764253035
  • 0364764124038
  • 0364764121037
  • Pharmacological Class

    • Dipeptidyl Peptidase 4 Inhibitors [MoA]
    • Dipeptidyl Peptidase 4 Inhibitor [EPC]
    • Peroxisome Proliferator-activated Receptor Activity [MoA]
    • PPAR alpha [CS]
    • PPAR gamma [CS]
    • Thiazolidinedione [EPC]
    • Thiazolidinediones [CS]
    • Peroxisome Proliferator Receptor alpha Agonist [EPC]
    • Peroxisome Proliferator Receptor gamma Agonist [EPC]

    NDC Crossover Matching brand name "OSENI" or generic name "Alogliptin And Pioglitazone"

    NDCBrand NameGeneric Name
    64764-121OSENIalogliptin and pioglitazone
    64764-123OSENIalogliptin and pioglitazone
    64764-124OSENIalogliptin and pioglitazone
    64764-251OSENIalogliptin and pioglitazone
    64764-253OSENIalogliptin and pioglitazone
    64764-254OSENIalogliptin and pioglitazone

    Trademark Results [OSENI]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    OSENI
    OSENI
    77387828 3765572 Live/Registered
    Takeda Pharmaceutical Company Limited
    2008-02-04

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