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 50 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-5040
Product ID 55154-5040_f843c4d2-5112-42bf-b060-ed74648d922e
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 551545040
Hyphenated Format 55154-5040

Supplemental Identifiers

RxCUI
665044 2709608
UPC
0355154504080
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
  • 50 mg/1
source: ndc
Packaging
  • 2340 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-5040-8)
source: ndc

Packages (1)

55154-5040-8 2340 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-5040-8)

Ingredients (1)

sitagliptin phosphate (50 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": "f843c4d2-5112-42bf-b060-ed74648d922e", "openfda": {"upc": ["0355154504080"], "unii": ["TS63EW8X6F"], "rxcui": ["665044", "2709608"], "spl_set_id": ["39253ddd-0245-43b1-ad28-d5923983afb4"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "2340 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-5040-8)", "package_ndc": "55154-5040-8", "marketing_start_date": "20061016"}], "brand_name": "JANUVIA", "product_id": "55154-5040_f843c4d2-5112-42bf-b060-ed74648d922e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "55154-5040", "generic_name": "sitagliptin", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "JANUVIA", "active_ingredients": [{"name": "SITAGLIPTIN PHOSPHATE", "strength": "50 mg/1"}], "application_number": "NDA021995", "marketing_category": "NDA", "marketing_start_date": "20061016", "listing_expiration_date": "20261231"}