xarelto

Generic: rivaroxaban

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

Drug Facts

Product Profile

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

rivaroxaban 10 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-1422
Product ID 55154-1422_fcb2aab9-1150-4d49-baf7-d03e0551d3c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022406
Listing Expiration 2027-12-31
Marketing Start 2011-07-01

Pharmacologic Class

Established (EPC)
factor xa inhibitor [epc]
Mechanism of Action
factor xa inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551541422
Hyphenated Format 55154-1422

Supplemental Identifiers

RxCUI
1114198 1114202 1232082 1232084 1232086 1232088
UPC
0355154142480 0350458579307 0055154142205
UNII
9NDF7JZ4M3
NUI
N0000175635 N0000175637

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 xarelto (source: ndc)
Generic Name rivaroxaban (source: ndc)
Application Number NDA022406 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-1422-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

55154-1422-0 10 BLISTER PACK in 1 BAG (55154-1422-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

rivaroxaban (10 mg/1)

Linked Drug Pages (1)

Xarelto ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fcb2aab9-1150-4d49-baf7-d03e0551d3c3", "openfda": {"nui": ["N0000175635", "N0000175637"], "upc": ["0355154142480", "0350458579307", "0055154142205"], "unii": ["9NDF7JZ4M3"], "rxcui": ["1114198", "1114202", "1232082", "1232084", "1232086", "1232088"], "spl_set_id": ["d0e105f6-28f3-45ee-83bd-7d458835242b"], "pharm_class_epc": ["Factor Xa Inhibitor [EPC]"], "pharm_class_moa": ["Factor Xa Inhibitors [MoA]"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-1422-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55154-1422-0", "marketing_start_date": "20110701"}], "brand_name": "Xarelto", "product_id": "55154-1422_fcb2aab9-1150-4d49-baf7-d03e0551d3c3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "55154-1422", "generic_name": "rivaroxaban", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xarelto", "active_ingredients": [{"name": "RIVAROXABAN", "strength": "10 mg/1"}], "application_number": "NDA022406", "marketing_category": "NDA", "marketing_start_date": "20110701", "listing_expiration_date": "20271231"}