januvia

Generic: sitagliptin

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name januvia
Generic Name sitagliptin
Labeler cardinal health 107, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sitagliptin phosphate 100 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-5042
Product ID 55154-5042_a4967ec8-0c3d-4e7f-a271-b8043bcac46b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021995
Listing Expiration 2026-12-31
Marketing Start 2006-10-16

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 551545042
Hyphenated Format 55154-5042

Supplemental Identifiers

RxCUI
665036 2709603
UNII
TS63EW8X6F

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 januvia (source: ndc)
Generic Name sitagliptin (source: ndc)
Application Number NDA021995 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1350 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-5042-8)
source: ndc

Packages (1)

55154-5042-8 1350 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-5042-8)

Ingredients (1)

sitagliptin phosphate (100 mg/1)

Linked Drug Pages (1)

JANUVIA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a4967ec8-0c3d-4e7f-a271-b8043bcac46b", "openfda": {"unii": ["TS63EW8X6F"], "rxcui": ["665036", "2709603"], "spl_set_id": ["9d558f96-24a5-4788-8933-38256c17384b"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1350 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-5042-8)", "package_ndc": "55154-5042-8", "marketing_start_date": "20061016"}], "brand_name": "JANUVIA", "product_id": "55154-5042_a4967ec8-0c3d-4e7f-a271-b8043bcac46b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "55154-5042", "generic_name": "sitagliptin", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "JANUVIA", "active_ingredients": [{"name": "SITAGLIPTIN PHOSPHATE", "strength": "100 mg/1"}], "application_number": "NDA021995", "marketing_category": "NDA", "marketing_start_date": "20061016", "listing_expiration_date": "20261231"}