januvia

Generic: sitagliptin

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name januvia
Generic Name sitagliptin
Labeler merck sharp & dohme llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sitagliptin phosphate 25 mg/1

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 0006-0221
Product ID 0006-0221_71d449de-955b-4711-9a44-1e1f66e2e9eb
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 00060221
Hyphenated Format 0006-0221

Supplemental Identifiers

RxCUI
665036 665040 665044 2709603 2709608 2709612
UPC
0300060112317 0300060221316 0300060277313
UNII
TS63EW8X6F

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

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0006-0221-28) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-0221-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (0006-0221-31)
  • 90 TABLET, FILM COATED in 1 BOTTLE (0006-0221-54)
source: ndc

Packages (3)

0006-0221-28 100 BLISTER PACK in 1 CARTON (0006-0221-28) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-0221-01) 0006-0221-31 30 TABLET, FILM COATED in 1 BOTTLE (0006-0221-31) 0006-0221-54 90 TABLET, FILM COATED in 1 BOTTLE (0006-0221-54)

Ingredients (1)

sitagliptin phosphate (25 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": "71d449de-955b-4711-9a44-1e1f66e2e9eb", "openfda": {"upc": ["0300060112317", "0300060221316", "0300060277313"], "unii": ["TS63EW8X6F"], "rxcui": ["665036", "665040", "665044", "2709603", "2709608", "2709612"], "spl_set_id": ["f85a48d0-0407-4c50-b0fa-7673a160bf01"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0006-0221-28)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-0221-01)", "package_ndc": "0006-0221-28", "marketing_start_date": "20061016"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0006-0221-31)", "package_ndc": "0006-0221-31", "marketing_start_date": "20061016"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (0006-0221-54)", "package_ndc": "0006-0221-54", "marketing_start_date": "20061016"}], "brand_name": "JANUVIA", "product_id": "0006-0221_71d449de-955b-4711-9a44-1e1f66e2e9eb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dipeptidyl Peptidase 4 Inhibitor [EPC]", "Dipeptidyl Peptidase 4 Inhibitors [MoA]"], "product_ndc": "0006-0221", "generic_name": "sitagliptin", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "JANUVIA", "active_ingredients": [{"name": "SITAGLIPTIN PHOSPHATE", "strength": "25 mg/1"}], "application_number": "NDA021995", "marketing_category": "NDA", "marketing_start_date": "20061016", "listing_expiration_date": "20261231"}