rivaroxaban

Generic: rivaroxaban

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

rivaroxaban 2.5 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-488
Product ID 33342-488_3149f574-855e-4a0f-bd0d-992dfec79495
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213114
Listing Expiration 2026-12-31
Marketing Start 2025-05-14

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 33342488
Hyphenated Format 33342-488

Supplemental Identifiers

RxCUI
2059015
UPC
0333342488572
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 ANDA213114 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (33342-488-09)
  • 180 TABLET, FILM COATED in 1 BOTTLE (33342-488-57)
  • 10 BLISTER PACK in 1 CARTON (33342-488-98) / 6 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

33342-488-09 60 TABLET, FILM COATED in 1 BOTTLE (33342-488-09) 33342-488-57 180 TABLET, FILM COATED in 1 BOTTLE (33342-488-57) 33342-488-98 10 BLISTER PACK in 1 CARTON (33342-488-98) / 6 TABLET, FILM COATED in 1 BLISTER PACK

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": "3149f574-855e-4a0f-bd0d-992dfec79495", "openfda": {"nui": ["N0000175635", "N0000175637"], "upc": ["0333342488572"], "unii": ["9NDF7JZ4M3"], "rxcui": ["2059015"], "spl_set_id": ["57717a31-d9d3-4246-90c0-4e4c0a29adf5"], "pharm_class_epc": ["Factor Xa Inhibitor [EPC]"], "pharm_class_moa": ["Factor Xa Inhibitors [MoA]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (33342-488-09)", "package_ndc": "33342-488-09", "marketing_start_date": "20250514"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (33342-488-57)", "package_ndc": "33342-488-57", "marketing_start_date": "20250514"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-488-98)  / 6 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-488-98", "marketing_start_date": "20250514"}], "brand_name": "Rivaroxaban", "product_id": "33342-488_3149f574-855e-4a0f-bd0d-992dfec79495", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "33342-488", "generic_name": "Rivaroxaban", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rivaroxaban", "active_ingredients": [{"name": "RIVAROXABAN", "strength": "2.5 mg/1"}], "application_number": "ANDA213114", "marketing_category": "ANDA", "marketing_start_date": "20250514", "listing_expiration_date": "20261231"}