rivaroxaban

Generic: rivaroxaban

Labeler: florida pharmaceutical products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rivaroxaban
Generic Name rivaroxaban
Labeler florida pharmaceutical products, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

rivaroxaban 2.5 mg/1

Manufacturer
Florida Pharmaceutical Products, LLC

Identifiers & Regulatory

Product NDC 71921-405
Product ID 71921-405_f0ef9361-f06d-4028-97af-183b545f4aea
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218445
Listing Expiration 2026-12-31
Marketing Start 2025-08-20

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 71921405
Hyphenated Format 71921-405

Supplemental Identifiers

RxCUI
2059015
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 ANDA218445 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (71921-405-06)
  • 180 TABLET in 1 BOTTLE (71921-405-21)
source: ndc

Packages (2)

71921-405-06 60 TABLET in 1 BOTTLE (71921-405-06) 71921-405-21 180 TABLET in 1 BOTTLE (71921-405-21)

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": "f0ef9361-f06d-4028-97af-183b545f4aea", "openfda": {"nui": ["N0000175635", "N0000175637"], "unii": ["9NDF7JZ4M3"], "rxcui": ["2059015"], "spl_set_id": ["f0ef9361-f06d-4028-97af-183b545f4aea"], "pharm_class_epc": ["Factor Xa Inhibitor [EPC]"], "pharm_class_moa": ["Factor Xa Inhibitors [MoA]"], "manufacturer_name": ["Florida Pharmaceutical Products, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (71921-405-06)", "package_ndc": "71921-405-06", "marketing_start_date": "20250820"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (71921-405-21)", "package_ndc": "71921-405-21", "marketing_start_date": "20250820"}], "brand_name": "rivaroxaban", "product_id": "71921-405_f0ef9361-f06d-4028-97af-183b545f4aea", "dosage_form": "TABLET", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "71921-405", "generic_name": "rivaroxaban", "labeler_name": "Florida Pharmaceutical Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "rivaroxaban", "active_ingredients": [{"name": "RIVAROXABAN", "strength": "2.5 mg/1"}], "application_number": "ANDA218445", "marketing_category": "ANDA", "marketing_start_date": "20250820", "listing_expiration_date": "20261231"}