savaysa

Generic: edoxaban tosylate

Labeler: daiichi sankyo inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name savaysa
Generic Name edoxaban tosylate
Labeler daiichi sankyo inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

edoxaban tosylate 30 mg/1

Manufacturer
Daiichi Sankyo Inc.

Identifiers & Regulatory

Product NDC 65597-202
Product ID 65597-202_dc54247c-0158-4cae-b692-914717ab3a67
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206316
Listing Expiration 2026-12-31
Marketing Start 2015-01-12

Pharmacologic Class

Classes
factor xa inhibitor [epc] factor xa inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65597202
Hyphenated Format 65597-202

Supplemental Identifiers

RxCUI
1599543 1599549 1599551 1599553 1599555 1599557
UPC
0365597202306 0365597201309
UNII
32W99UE810

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 savaysa (source: ndc)
Generic Name edoxaban tosylate (source: ndc)
Application Number NDA206316 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 CARTON (65597-202-05) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 7 TABLET, FILM COATED in 1 BOTTLE (65597-202-07)
  • 100 BLISTER PACK in 1 CARTON (65597-202-10) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (65597-202-30)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65597-202-50)
  • 7 TABLET, FILM COATED in 1 BLISTER PACK (65597-202-70)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65597-202-90)
source: ndc

Packages (7)

Ingredients (1)

edoxaban tosylate (30 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "dc54247c-0158-4cae-b692-914717ab3a67", "openfda": {"upc": ["0365597202306", "0365597201309"], "unii": ["32W99UE810"], "rxcui": ["1599543", "1599549", "1599551", "1599553", "1599555", "1599557"], "spl_set_id": ["e77d3400-56ad-11e3-949a-0800200c9a66"], "manufacturer_name": ["Daiichi Sankyo Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (65597-202-05)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65597-202-05", "marketing_start_date": "20150131"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE (65597-202-07)", "package_ndc": "65597-202-07", "marketing_start_date": "20150131"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (65597-202-10)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65597-202-10", "marketing_start_date": "20150131"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65597-202-30)", "package_ndc": "65597-202-30", "marketing_start_date": "20150131"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65597-202-50)", "package_ndc": "65597-202-50", "marketing_start_date": "20150131"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BLISTER PACK (65597-202-70)", "package_ndc": "65597-202-70", "marketing_start_date": "20150131"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65597-202-90)", "package_ndc": "65597-202-90", "marketing_start_date": "20150131"}], "brand_name": "SAVAYSA", "product_id": "65597-202_dc54247c-0158-4cae-b692-914717ab3a67", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "65597-202", "generic_name": "EDOXABAN TOSYLATE", "labeler_name": "Daiichi Sankyo Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SAVAYSA", "active_ingredients": [{"name": "EDOXABAN TOSYLATE", "strength": "30 mg/1"}], "application_number": "NDA206316", "marketing_category": "NDA", "marketing_start_date": "20150112", "listing_expiration_date": "20261231"}