oseni

Generic: alogliptin and pioglitazone

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name oseni
Generic Name alogliptin and pioglitazone
Labeler takeda pharmaceuticals america, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

alogliptin benzoate 25 mg/1, pioglitazone hydrochloride 30 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 64764-253
Product ID 64764-253_2346b7f5-b2c1-45f0-9f8f-5cbb4b202857
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022426
Listing Expiration 2026-12-31
Marketing Start 2013-01-25

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64764253
Hyphenated Format 64764-253

Supplemental Identifiers

RxCUI
1368410 1368416 1368424 1368430 1368431 1368437 1368438 1368444
UPC
0364764251031 0364764253035 0364764254032 0364764123031
UNII
JQT35NPK6C EEN99869SC

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name oseni (source: ndc)
Generic Name alogliptin and pioglitazone (source: ndc)
Application Number NDA022426 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 30 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (64764-253-03)
  • 90 TABLET, FILM COATED in 1 BOTTLE (64764-253-04)
  • 500 TABLET, FILM COATED in 1 BOTTLE (64764-253-05)
source: ndc

Packages (3)

64764-253-03 30 TABLET, FILM COATED in 1 BOTTLE (64764-253-03) 64764-253-04 90 TABLET, FILM COATED in 1 BOTTLE (64764-253-04) 64764-253-05 500 TABLET, FILM COATED in 1 BOTTLE (64764-253-05)

Ingredients (2)

alogliptin benzoate (25 mg/1) pioglitazone hydrochloride (30 mg/1)

Linked Drug Pages (1)

OSENI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2346b7f5-b2c1-45f0-9f8f-5cbb4b202857", "openfda": {"upc": ["0364764251031", "0364764253035", "0364764254032", "0364764123031"], "unii": ["JQT35NPK6C", "EEN99869SC"], "rxcui": ["1368410", "1368416", "1368424", "1368430", "1368431", "1368437", "1368438", "1368444"], "spl_set_id": ["4c619ed9-fe3e-4158-9938-80c6c3493d55"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (64764-253-03)", "package_ndc": "64764-253-03", "marketing_start_date": "20130125"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (64764-253-04)", "package_ndc": "64764-253-04", "marketing_start_date": "20130125"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (64764-253-05)", "package_ndc": "64764-253-05", "marketing_start_date": "20130125"}], "brand_name": "OSENI", "product_id": "64764-253_2346b7f5-b2c1-45f0-9f8f-5cbb4b202857", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["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]"], "product_ndc": "64764-253", "generic_name": "alogliptin and pioglitazone", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OSENI", "active_ingredients": [{"name": "ALOGLIPTIN BENZOATE", "strength": "25 mg/1"}, {"name": "PIOGLITAZONE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "NDA022426", "marketing_category": "NDA", "marketing_start_date": "20130125", "listing_expiration_date": "20261231"}