xarelto

Generic: rivaroxaban

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

Drug Facts

Product Profile

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

rivaroxaban 10 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-3625
Product ID 50090-3625_555f1ee6-225c-4834-b936-cdad8f836f81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022406
Listing Expiration 2026-12-31
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 500903625
Hyphenated Format 50090-3625

Supplemental Identifiers

RxCUI
1114198 1114202
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
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-3625-0)
  • 12 TABLET, FILM COATED in 1 BOTTLE (50090-3625-1)
source: ndc

Packages (2)

50090-3625-0 90 TABLET, FILM COATED in 1 BOTTLE (50090-3625-0) 50090-3625-1 12 TABLET, FILM COATED in 1 BOTTLE (50090-3625-1)

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": "555f1ee6-225c-4834-b936-cdad8f836f81", "openfda": {"nui": ["N0000175635", "N0000175637"], "unii": ["9NDF7JZ4M3"], "rxcui": ["1114198", "1114202"], "spl_set_id": ["7e9ab975-db2f-423c-a089-bc5a73313609"], "pharm_class_epc": ["Factor Xa Inhibitor [EPC]"], "pharm_class_moa": ["Factor Xa Inhibitors [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-3625-0)", "package_ndc": "50090-3625-0", "marketing_start_date": "20181006"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE (50090-3625-1)", "package_ndc": "50090-3625-1", "marketing_start_date": "20240515"}], "brand_name": "Xarelto", "product_id": "50090-3625_555f1ee6-225c-4834-b936-cdad8f836f81", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "50090-3625", "generic_name": "rivaroxaban", "labeler_name": "A-S Medication Solutions", "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": "20261231"}