januvia

Generic: sitagliptin

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name januvia
Generic Name sitagliptin
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sitagliptin phosphate 100 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5585
Product ID 50090-5585_cfeddd56-d91c-42ee-91d2-98e5cf752e55
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 500905585
Hyphenated Format 50090-5585

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
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-5585-0)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-5585-1)
source: ndc

Packages (2)

50090-5585-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-5585-0) 50090-5585-1 90 TABLET, FILM COATED in 1 BOTTLE (50090-5585-1)

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": "cfeddd56-d91c-42ee-91d2-98e5cf752e55", "openfda": {"unii": ["TS63EW8X6F"], "rxcui": ["665036", "2709603"], "spl_set_id": ["24e22e28-ec43-47e8-969f-788268ccba12"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-5585-0)", "package_ndc": "50090-5585-0", "marketing_start_date": "20210709"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-5585-1)", "package_ndc": "50090-5585-1", "marketing_start_date": "20210709"}], "brand_name": "JANUVIA", "product_id": "50090-5585_cfeddd56-d91c-42ee-91d2-98e5cf752e55", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "50090-5585", "generic_name": "sitagliptin", "labeler_name": "A-S Medication Solutions", "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"}