alogliptin and metformin hydrochloride

Generic: alogliptin and metformin hydrochloride

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

Drug Facts

Product Profile

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

alogliptin benzoate 12.5 mg/1, metformin hydrochloride 1000 mg/1

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-211
Product ID 45802-211_187b18ba-520f-45dd-9d6f-57a833962da1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA203414
Listing Expiration 2026-12-31
Marketing Start 2016-04-08

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs] dipeptidyl peptidase 4 inhibitor [epc] dipeptidyl peptidase 4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802211
Hyphenated Format 45802-211

Supplemental Identifiers

RxCUI
1368385 1368392
UPC
0345802169723 0345802211729
UNII
EEN99869SC 786Z46389E

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 metformin hydrochloride (source: ndc)
Generic Name alogliptin and metformin hydrochloride (source: ndc)
Application Number NDA203414 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
  • 1000 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (45802-211-72)
source: ndc

Packages (1)

45802-211-72 60 TABLET, FILM COATED in 1 BOTTLE (45802-211-72)

Ingredients (2)

alogliptin benzoate (12.5 mg/1) metformin hydrochloride (1000 mg/1)

Linked Drug Pages (1)

alogliptin and metformin hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "187b18ba-520f-45dd-9d6f-57a833962da1", "openfda": {"upc": ["0345802169723", "0345802211729"], "unii": ["EEN99869SC", "786Z46389E"], "rxcui": ["1368385", "1368392"], "spl_set_id": ["14d98490-4f8f-4d2f-a4e9-7a3d7a0199ba"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (45802-211-72)", "package_ndc": "45802-211-72", "marketing_start_date": "20160408"}], "brand_name": "alogliptin and metformin hydrochloride", "product_id": "45802-211_187b18ba-520f-45dd-9d6f-57a833962da1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]", "Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "45802-211", "generic_name": "alogliptin and metformin hydrochloride", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "alogliptin and metformin hydrochloride", "active_ingredients": [{"name": "ALOGLIPTIN BENZOATE", "strength": "12.5 mg/1"}, {"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "NDA203414", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20160408", "listing_expiration_date": "20261231"}