rivaroxaban

Generic: rivaroxaban

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

Drug Facts

Product Profile

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

rivaroxaban 2.5 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-683
Product ID 46708-683_4b61dc52-0593-4ef0-8246-a82ff6972842
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210301
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 46708683
Hyphenated Format 46708-683

Supplemental Identifiers

RxCUI
1114198 1232082 1232086 1549682 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 ANDA210301 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (46708-683-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 180 TABLET, FILM COATED in 1 BOTTLE (46708-683-45)
  • 60 TABLET, FILM COATED in 1 BOTTLE (46708-683-60)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (46708-683-91)
source: ndc

Packages (4)

46708-683-10 100 BLISTER PACK in 1 CARTON (46708-683-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 46708-683-45 180 TABLET, FILM COATED in 1 BOTTLE (46708-683-45) 46708-683-60 60 TABLET, FILM COATED in 1 BOTTLE (46708-683-60) 46708-683-91 1000 TABLET, FILM COATED in 1 BOTTLE (46708-683-91)

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": "4b61dc52-0593-4ef0-8246-a82ff6972842", "openfda": {"nui": ["N0000175635", "N0000175637"], "unii": ["9NDF7JZ4M3"], "rxcui": ["1114198", "1232082", "1232086", "1549682", "2059015"], "spl_set_id": ["5524f30f-789d-4f5c-8f7c-d03a475b6d34"], "pharm_class_epc": ["Factor Xa Inhibitor [EPC]"], "pharm_class_moa": ["Factor Xa Inhibitors [MoA]"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (46708-683-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "46708-683-10", "marketing_start_date": "20250514"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (46708-683-45)", "package_ndc": "46708-683-45", "marketing_start_date": "20250514"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (46708-683-60)", "package_ndc": "46708-683-60", "marketing_start_date": "20250514"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (46708-683-91)", "package_ndc": "46708-683-91", "marketing_start_date": "20250514"}], "brand_name": "RIVAROXABAN", "product_id": "46708-683_4b61dc52-0593-4ef0-8246-a82ff6972842", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "46708-683", "generic_name": "RIVAROXABAN", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RIVAROXABAN", "active_ingredients": [{"name": "RIVAROXABAN", "strength": "2.5 mg/1"}], "application_number": "ANDA210301", "marketing_category": "ANDA", "marketing_start_date": "20250514", "listing_expiration_date": "20261231"}