alogliptin

Generic: alogliptin

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name alogliptin
Generic Name alogliptin
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

alogliptin benzoate 25 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-300
Product ID 71610-300_a8ff5402-3a49-4f04-9868-f8b2dff3aa99
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022271
Listing Expiration 2026-12-31
Marketing Start 2016-04-08

Pharmacologic Class

Classes
dipeptidyl peptidase 4 inhibitor [epc] dipeptidyl peptidase 4 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610300
Hyphenated Format 71610-300

Supplemental Identifiers

RxCUI
1368006
UNII
EEN99869SC

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 (source: ndc)
Generic Name alogliptin (source: ndc)
Application Number NDA022271 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 9000 TABLET, FILM COATED in 1 BOTTLE (71610-300-09)
  • 3000 TABLET, FILM COATED in 1 BOTTLE (71610-300-18)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-300-60)
source: ndc

Packages (3)

71610-300-09 9000 TABLET, FILM COATED in 1 BOTTLE (71610-300-09) 71610-300-18 3000 TABLET, FILM COATED in 1 BOTTLE (71610-300-18) 71610-300-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-300-60)

Ingredients (1)

alogliptin benzoate (25 mg/1)

Linked Drug Pages (1)

Alogliptin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a8ff5402-3a49-4f04-9868-f8b2dff3aa99", "openfda": {"unii": ["EEN99869SC"], "rxcui": ["1368006"], "spl_set_id": ["4b007011-547a-498e-b8f6-34ea4ea00eb4"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "9000 TABLET, FILM COATED in 1 BOTTLE (71610-300-09)", "package_ndc": "71610-300-09", "marketing_start_date": "20190703"}, {"sample": false, "description": "3000 TABLET, FILM COATED in 1 BOTTLE (71610-300-18)", "package_ndc": "71610-300-18", "marketing_start_date": "20220125"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-300-60)", "package_ndc": "71610-300-60", "marketing_start_date": "20230202"}], "brand_name": "Alogliptin", "product_id": "71610-300_a8ff5402-3a49-4f04-9868-f8b2dff3aa99", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "71610-300", "generic_name": "Alogliptin", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alogliptin", "active_ingredients": [{"name": "ALOGLIPTIN BENZOATE", "strength": "25 mg/1"}], "application_number": "NDA022271", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20160408", "listing_expiration_date": "20261231"}