xarelto

Generic: rivaroxaban

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xarelto
Generic Name rivaroxaban
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rivaroxaban 10 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-690
Product ID 71610-690_d0758929-1cc8-4ac2-807e-969a8c7f6c77
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 71610690
Hyphenated Format 71610-690

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
  • 1800 TABLET, FILM COATED in 1 BOTTLE (71610-690-42)
source: ndc

Packages (1)

71610-690-42 1800 TABLET, FILM COATED in 1 BOTTLE (71610-690-42)

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": "d0758929-1cc8-4ac2-807e-969a8c7f6c77", "openfda": {"nui": ["N0000175635", "N0000175637"], "unii": ["9NDF7JZ4M3"], "rxcui": ["1114198", "1114202"], "spl_set_id": ["38b11f5d-f0fc-46dc-aef1-ea31872bb621"], "pharm_class_epc": ["Factor Xa Inhibitor [EPC]"], "pharm_class_moa": ["Factor Xa Inhibitors [MoA]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1800 TABLET, FILM COATED in 1 BOTTLE (71610-690-42)", "package_ndc": "71610-690-42", "marketing_start_date": "20230217"}], "brand_name": "Xarelto", "product_id": "71610-690_d0758929-1cc8-4ac2-807e-969a8c7f6c77", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "71610-690", "generic_name": "rivaroxaban", "labeler_name": "Aphena Pharma Solutions - Tennessee, 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": "20261231"}