rivaroxaban

Generic: rivaroxaban

Labeler: sciegen pharmaceuticals,inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

rivaroxaban 2.5 mg/1

Manufacturer
ScieGen pharmaceuticals,Inc

Identifiers & Regulatory

Product NDC 50228-513
Product ID 50228-513_3b53cebf-946d-b82b-e063-6394a90a5da7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218117
Listing Expiration 2026-12-31
Marketing Start 2025-08-04

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 50228513
Hyphenated Format 50228-513

Supplemental Identifiers

RxCUI
2059015
UPC
0350228513180 0350228513609
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 ANDA218117 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 180 TABLET, FILM COATED in 1 BOTTLE (50228-513-18)
  • 60 TABLET, FILM COATED in 1 BOTTLE (50228-513-60)
source: ndc

Packages (2)

50228-513-18 180 TABLET, FILM COATED in 1 BOTTLE (50228-513-18) 50228-513-60 60 TABLET, FILM COATED in 1 BOTTLE (50228-513-60)

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": "3b53cebf-946d-b82b-e063-6394a90a5da7", "openfda": {"nui": ["N0000175635", "N0000175637"], "upc": ["0350228513180", "0350228513609"], "unii": ["9NDF7JZ4M3"], "rxcui": ["2059015"], "spl_set_id": ["3b53cebf-946c-b82b-e063-6394a90a5da7"], "pharm_class_epc": ["Factor Xa Inhibitor [EPC]"], "pharm_class_moa": ["Factor Xa Inhibitors [MoA]"], "manufacturer_name": ["ScieGen pharmaceuticals,Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (50228-513-18)", "package_ndc": "50228-513-18", "marketing_start_date": "20250804"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (50228-513-60)", "package_ndc": "50228-513-60", "marketing_start_date": "20250804"}], "brand_name": "Rivaroxaban", "product_id": "50228-513_3b53cebf-946d-b82b-e063-6394a90a5da7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "50228-513", "generic_name": "Rivaroxaban", "labeler_name": "ScieGen pharmaceuticals,Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rivaroxaban", "active_ingredients": [{"name": "RIVAROXABAN", "strength": "2.5 mg/1"}], "application_number": "ANDA218117", "marketing_category": "ANDA", "marketing_start_date": "20250804", "listing_expiration_date": "20261231"}