xarelto

Generic: rivaroxaban

Labeler: janssen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xarelto
Generic Name rivaroxaban
Labeler janssen pharmaceuticals, inc.
Dosage Form KIT
Manufacturer
Janssen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50458-584
Product ID 50458-584_48884709-657d-6712-e063-6394a90a88e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022406
Listing Expiration 2027-12-31
Marketing Start 2014-09-16

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 50458584
Hyphenated Format 50458-584

Supplemental Identifiers

RxCUI
1114198 1114202 1232082 1232084 1232086 1232088 1549682 1549683 2059015 2059017 2588062 2588066
UPC
0350458575019 0350458579307 0350458580303 0350458578300 0350458577600
UNII
9NDF7JZ4M3
NUI
N0000175635 N0000175637

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

Resolved Composition

Strengths
  • 2.5 mg
  • 10 mg
  • 15 mg
  • 20 mg
  • 1 mg/ml
  • 155 mg
  • 150 ml
  • 1 ml
  • 1 mg
source: label
Packaging
  • 1 KIT in 1 CARTON (50458-584-51) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 9 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 KIT in 1 CARTON (50458-584-52) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 9 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

50458-584-51 1 KIT in 1 CARTON (50458-584-51) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 9 TABLET, FILM COATED in 1 BLISTER PACK 50458-584-52 1 KIT in 1 CARTON (50458-584-52) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 9 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Xarelto, XARELTO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "48884709-657d-6712-e063-6394a90a88e7", "openfda": {"nui": ["N0000175635", "N0000175637"], "upc": ["0350458575019", "0350458579307", "0350458580303", "0350458578300", "0350458577600"], "unii": ["9NDF7JZ4M3"], "rxcui": ["1114198", "1114202", "1232082", "1232084", "1232086", "1232088", "1549682", "1549683", "2059015", "2059017", "2588062", "2588066"], "spl_set_id": ["10db92f9-2300-4a80-836b-673e1ae91610"], "pharm_class_epc": ["Factor Xa Inhibitor [EPC]"], "pharm_class_moa": ["Factor Xa Inhibitors [MoA]"], "manufacturer_name": ["Janssen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (50458-584-51)  *  42 TABLET, FILM COATED in 1 BLISTER PACK *  9 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50458-584-51", "marketing_start_date": "20140916"}, {"sample": false, "description": "1 KIT in 1 CARTON (50458-584-52)  *  42 TABLET, FILM COATED in 1 BLISTER PACK *  9 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50458-584-52", "marketing_start_date": "20161101"}], "brand_name": "XARELTO", "product_id": "50458-584_48884709-657d-6712-e063-6394a90a88e7", "dosage_form": "KIT", "product_ndc": "50458-584", "generic_name": "Rivaroxaban", "labeler_name": "Janssen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XARELTO", "application_number": "NDA022406", "marketing_category": "NDA", "marketing_start_date": "20140916", "listing_expiration_date": "20271231"}