rivaroxaban

Generic: rivaroxaban

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rivaroxaban
Generic Name rivaroxaban
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

rivaroxaban 2.5 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 51672-4228
Product ID 51672-4228_44213d0b-ca52-c6ac-e063-6394a90afd03
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208557
Listing Expiration 2026-12-31
Marketing Start 2025-10-15

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 516724228
Hyphenated Format 51672-4228

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 ANDA208557 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 60 TABLET, COATED in 1 BOTTLE (51672-4228-4)
  • 180 TABLET, COATED in 1 BOTTLE (51672-4228-9)
source: ndc

Packages (2)

51672-4228-4 60 TABLET, COATED in 1 BOTTLE (51672-4228-4) 51672-4228-9 180 TABLET, COATED in 1 BOTTLE (51672-4228-9)

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": "44213d0b-ca52-c6ac-e063-6394a90afd03", "openfda": {"nui": ["N0000175635", "N0000175637"], "unii": ["9NDF7JZ4M3"], "rxcui": ["2059015"], "spl_set_id": ["925a9a11-ae5b-405c-96d2-b1be4b85bf71"], "pharm_class_epc": ["Factor Xa Inhibitor [EPC]"], "pharm_class_moa": ["Factor Xa Inhibitors [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, COATED in 1 BOTTLE (51672-4228-4)", "package_ndc": "51672-4228-4", "marketing_start_date": "20251015"}, {"sample": false, "description": "180 TABLET, COATED in 1 BOTTLE (51672-4228-9)", "package_ndc": "51672-4228-9", "marketing_start_date": "20251015"}], "brand_name": "Rivaroxaban", "product_id": "51672-4228_44213d0b-ca52-c6ac-e063-6394a90afd03", "dosage_form": "TABLET, COATED", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "51672-4228", "generic_name": "Rivaroxaban", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rivaroxaban", "active_ingredients": [{"name": "RIVAROXABAN", "strength": "2.5 mg/1"}], "application_number": "ANDA208557", "marketing_category": "ANDA", "marketing_start_date": "20251015", "listing_expiration_date": "20261231"}