rivaroxaban

Generic: rivaroxaban

Labeler: indoco remedies limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

rivaroxaban 10 mg/1

Manufacturer
Indoco Remedies Limited

Identifiers & Regulatory

Product NDC 14445-148
Product ID 14445-148_b57414a3-eca8-4cda-b7eb-7c060d52a6b6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218445
Listing Expiration 2026-12-31
Marketing Start 2025-08-11

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 14445148
Hyphenated Format 14445-148

Supplemental Identifiers

RxCUI
1114198 1232082 1232086 2059015
UPC
0314445184301 0314445147603 0314445148303 0314445183304
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
  • 10 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (14445-148-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (14445-148-02)
  • 30 TABLET, FILM COATED in 1 BOTTLE (14445-148-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (14445-148-90)
source: ndc

Packages (3)

14445-148-10 10 BLISTER PACK in 1 CARTON (14445-148-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (14445-148-02) 14445-148-30 30 TABLET, FILM COATED in 1 BOTTLE (14445-148-30) 14445-148-90 90 TABLET, FILM COATED in 1 BOTTLE (14445-148-90)

Ingredients (1)

rivaroxaban (10 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": "b57414a3-eca8-4cda-b7eb-7c060d52a6b6", "openfda": {"nui": ["N0000175635", "N0000175637"], "upc": ["0314445184301", "0314445147603", "0314445148303", "0314445183304"], "unii": ["9NDF7JZ4M3"], "rxcui": ["1114198", "1232082", "1232086", "2059015"], "spl_set_id": ["9fee7136-c8fd-4bea-ab15-7a0e7292396d"], "pharm_class_epc": ["Factor Xa Inhibitor [EPC]"], "pharm_class_moa": ["Factor Xa Inhibitors [MoA]"], "manufacturer_name": ["Indoco Remedies Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (14445-148-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (14445-148-02)", "package_ndc": "14445-148-10", "marketing_start_date": "20250811"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (14445-148-30)", "package_ndc": "14445-148-30", "marketing_start_date": "20250811"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (14445-148-90)", "package_ndc": "14445-148-90", "marketing_start_date": "20250811"}], "brand_name": "Rivaroxaban", "product_id": "14445-148_b57414a3-eca8-4cda-b7eb-7c060d52a6b6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "14445-148", "generic_name": "Rivaroxaban", "labeler_name": "Indoco Remedies Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rivaroxaban", "active_ingredients": [{"name": "RIVAROXABAN", "strength": "10 mg/1"}], "application_number": "ANDA218445", "marketing_category": "ANDA", "marketing_start_date": "20250811", "listing_expiration_date": "20261231"}