alogliptin and pioglitazone

Generic: alogliptin benzoate and pioglitazone hydrochloride

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name alogliptin and pioglitazone
Generic Name alogliptin benzoate and pioglitazone hydrochloride
Labeler padagis israel pharmaceuticals ltd
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

alogliptin benzoate 25 mg/1, pioglitazone hydrochloride 45 mg/1

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-499
Product ID 45802-499_11c471e0-6c64-4f13-b6ed-d2c80bc89f20
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022426
Listing Expiration 2026-12-31
Marketing Start 2016-04-08

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 45802499
Hyphenated Format 45802-499

Supplemental Identifiers

RxCUI
1368410 1368424 1368431 1368438
UPC
0345802260659 0345802402653 0345802351654 0345802499653
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 alogliptin and pioglitazone (source: ndc)
Generic Name alogliptin benzoate and pioglitazone hydrochloride (source: ndc)
Application Number NDA022426 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 45 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (45802-499-65)
source: ndc

Packages (1)

45802-499-65 30 TABLET, FILM COATED in 1 BOTTLE (45802-499-65)

Ingredients (2)

alogliptin benzoate (25 mg/1) pioglitazone hydrochloride (45 mg/1)

Linked Drug Pages (1)

Alogliptin and Pioglitazone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "11c471e0-6c64-4f13-b6ed-d2c80bc89f20", "openfda": {"upc": ["0345802260659", "0345802402653", "0345802351654", "0345802499653"], "unii": ["JQT35NPK6C", "EEN99869SC"], "rxcui": ["1368410", "1368424", "1368431", "1368438"], "spl_set_id": ["642b1e90-701e-42f2-bac6-a4918738e2c9"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (45802-499-65)", "package_ndc": "45802-499-65", "marketing_start_date": "20160408"}], "brand_name": "Alogliptin and Pioglitazone", "product_id": "45802-499_11c471e0-6c64-4f13-b6ed-d2c80bc89f20", "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": "45802-499", "generic_name": "Alogliptin Benzoate and Pioglitazone hydrochloride", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alogliptin and Pioglitazone", "active_ingredients": [{"name": "ALOGLIPTIN BENZOATE", "strength": "25 mg/1"}, {"name": "PIOGLITAZONE HYDROCHLORIDE", "strength": "45 mg/1"}], "application_number": "NDA022426", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20160408", "listing_expiration_date": "20261231"}