rivaroxaban

Generic: rivaroxaban

Labeler: dr.reddy's laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name rivaroxaban
Generic Name rivaroxaban
Labeler dr.reddy's laboratories, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

rivaroxaban 2.5 mg/1

Manufacturer
Dr.Reddy's Laboratories, Inc.

Identifiers & Regulatory

Product NDC 43598-981
Product ID 43598-981_3304338b-452e-8abc-0e74-1b0c38ab31fe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208534
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 43598981
Hyphenated Format 43598-981

Supplemental Identifiers

RxCUI
2059015
UPC
0343598981604
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 ANDA208534 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 180 TABLET in 1 BOTTLE (43598-981-18)
  • 60 TABLET in 1 BOTTLE (43598-981-60)
  • 10 BLISTER PACK in 1 CARTON (43598-981-78) / 10 TABLET in 1 BLISTER PACK (43598-981-79)
source: ndc

Packages (3)

43598-981-18 180 TABLET in 1 BOTTLE (43598-981-18) 43598-981-60 60 TABLET in 1 BOTTLE (43598-981-60) 43598-981-78 10 BLISTER PACK in 1 CARTON (43598-981-78) / 10 TABLET in 1 BLISTER PACK (43598-981-79)

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": "3304338b-452e-8abc-0e74-1b0c38ab31fe", "openfda": {"nui": ["N0000175635", "N0000175637"], "upc": ["0343598981604"], "unii": ["9NDF7JZ4M3"], "rxcui": ["2059015"], "spl_set_id": ["122e6f78-067b-9065-adb2-ec7fec9f008e"], "pharm_class_epc": ["Factor Xa Inhibitor [EPC]"], "pharm_class_moa": ["Factor Xa Inhibitors [MoA]"], "manufacturer_name": ["Dr.Reddy's Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET in 1 BOTTLE (43598-981-18)", "package_ndc": "43598-981-18", "marketing_start_date": "20250514"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (43598-981-60)", "package_ndc": "43598-981-60", "marketing_start_date": "20250514"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (43598-981-78)  / 10 TABLET in 1 BLISTER PACK (43598-981-79)", "package_ndc": "43598-981-78", "marketing_start_date": "20250514"}], "brand_name": "Rivaroxaban", "product_id": "43598-981_3304338b-452e-8abc-0e74-1b0c38ab31fe", "dosage_form": "TABLET", "pharm_class": ["Factor Xa Inhibitor [EPC]", "Factor Xa Inhibitors [MoA]"], "product_ndc": "43598-981", "generic_name": "Rivaroxaban", "labeler_name": "Dr.Reddy's Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rivaroxaban", "active_ingredients": [{"name": "RIVAROXABAN", "strength": "2.5 mg/1"}], "application_number": "ANDA208534", "marketing_category": "ANDA", "marketing_start_date": "20250514", "listing_expiration_date": "20261231"}