rivaroxaban

Generic: rivaroxaban

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rivaroxaban
Generic Name rivaroxaban
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

rivaroxaban 2.5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-849
Product ID 59651-849_9c3503ce-8ffe-4ff2-a918-700c62f40642
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208544
Listing Expiration 2026-12-31
Marketing Start 2025-04-10

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 59651849
Hyphenated Format 59651-849

Supplemental Identifiers

RxCUI
2059015
UPC
0359651849606
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 rivaroxaban (source: ndc)
Generic Name rivaroxaban (source: ndc)
Application Number ANDA208544 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 180 TABLET, FILM COATED in 1 BOTTLE (59651-849-18)
  • 60 TABLET, FILM COATED in 1 BOTTLE (59651-849-60)
source: ndc

Packages (2)

59651-849-18 180 TABLET, FILM COATED in 1 BOTTLE (59651-849-18) 59651-849-60 60 TABLET, FILM COATED in 1 BOTTLE (59651-849-60)

Ingredients (1)

rivaroxaban (2.5 mg/1)

Linked Drug Pages (1)

Rivaroxaban ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9c3503ce-8ffe-4ff2-a918-700c62f40642", "openfda": {"nui": ["N0000175635", "N0000175637"], "upc": ["0359651849606"], "unii": ["9NDF7JZ4M3"], "rxcui": ["2059015"], "spl_set_id": ["bcb0e6e7-3006-4d82-8009-c5fddbbfc80d"], "pharm_class_epc": ["Factor Xa Inhibitor [EPC]"], "pharm_class_moa": ["Factor Xa Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (59651-849-18)", "package_ndc": "59651-849-18", "marketing_start_date": "20250410"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (59651-849-60)", "package_ndc": "59651-849-60", "marketing_start_date": "20250410"}], "brand_name": "Rivaroxaban", "product_id": "59651-849_9c3503ce-8ffe-4ff2-a918-700c62f40642", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "59651-849", "generic_name": "Rivaroxaban", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rivaroxaban", "active_ingredients": [{"name": "RIVAROXABAN", "strength": "2.5 mg/1"}], "application_number": "ANDA208544", "marketing_category": "ANDA", "marketing_start_date": "20250410", "listing_expiration_date": "20261231"}