NDC 64764-123

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 ID: 64764-123_49bce7dd-24dc-4a5c-b7d9-68446011e478
• NDC: 64764-123
• Product Type: Human Prescription Drug
• Proprietary Name: OSENI
• Generic Name: Alogliptin And Pioglitazone
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2013-01-25
• Marketing Category: NDA / NDA
• Application Number: NDA022426
• Labeler Name: Takeda Pharmaceuticals America, Inc.
• Substance Name: ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
• Active Ingredient Strength: 13 mg/1; mg/1
• Pharm Classes: 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 Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 64764-123-03

30 TABLET, FILM COATED in 1 BOTTLE (64764-123-03)

• Marketing Start Date: 2013-01-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64764-123-03 [64764012303]

OSENI TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022426
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-01-25

NDC 64764-123-05 [64764012305]

OSENI TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022426
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-01-25

NDC 64764-123-04 [64764012304]

OSENI TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022426
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-01-25

NDC 64764-123-06 [64764012306]

OSENI TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022426
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2013-01-25
• Marketing End Date: 2018-01-05

Drug Details

Active Ingredients

Ingredient	Strength
ALOGLIPTIN BENZOATE	12.5 mg/1

OpenFDA Data

• SPL SET ID: 4c619ed9-fe3e-4158-9938-80c6c3493d55
• Manufacturer:
  • Takeda Pharmaceuticals America, Inc.
• UNII:
  • JQT35NPK6C
  • EEN99869SC
• 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"

NDC	Brand Name	Generic Name
64764-121	OSENI	alogliptin and pioglitazone
64764-123	OSENI	alogliptin and pioglitazone
64764-124	OSENI	alogliptin and pioglitazone
64764-251	OSENI	alogliptin and pioglitazone
64764-253	OSENI	alogliptin and pioglitazone
64764-254	OSENI	alogliptin and pioglitazone