NDC 50458-580

Xarelto

Rivaroxaban

Xarelto is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Janssen Pharmaceuticals, Inc.. The primary component is Rivaroxaban.

• Product ID: 50458-580_271c2898-67e5-11e9-974e-d1c20099106d
• NDC: 50458-580
• Product Type: Human Prescription Drug
• Proprietary Name: Xarelto
• Generic Name: Rivaroxaban
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2011-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA022406
• Labeler Name: Janssen Pharmaceuticals, Inc.
• Substance Name: RIVAROXABAN
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50458-580-07

7 TABLET, FILM COATED in 1 BOTTLE (50458-580-07)

• Marketing Start Date: 2017-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50458-580-10 [50458058010]

Xarelto TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022406
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-07-01

NDC 50458-580-01 [50458058001]

Xarelto TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022406
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-25

NDC 50458-580-90 [50458058090]

Xarelto TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022406
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-11-01

NDC 50458-580-30 [50458058030]

Xarelto TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022406
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-07-01

NDC 50458-580-07 [50458058007]

Xarelto TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022406
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-11-01

Drug Details

Active Ingredients

Ingredient	Strength
RIVAROXABAN	10 mg/1

OpenFDA Data

• SPL SET ID: 10db92f9-2300-4a80-836b-673e1ae91610
• Manufacturer:
  • Janssen Pharmaceuticals, Inc.
• UNII:
  • 9NDF7JZ4M3
• RxNorm Concept Unique ID - RxCUI:
  • 1114198
  • 1549683
  • 1114202
  • 1549682
  • 1232088
  • 2059015
  • 2059017
  • 1232082
  • 1232084
  • 1232086

Pharmacological Class

• Factor Xa Inhibitors [MoA]
• Factor Xa Inhibitor [EPC]

Medicade Reported Pricing

50458058090 XARELTO 10 MG TABLET

Pricing Unit: EA | Drug Type:

50458058030 XARELTO 10 MG TABLET

Pricing Unit: EA | Drug Type:

50458058010 XARELTO 10 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Xarelto" or generic name "Rivaroxaban"

NDC	Brand Name	Generic Name
50090-3625	Xarelto	rivaroxaban
50090-3639	Xarelto	rivaroxaban
50090-4468	Xarelto	rivaroxaban
50090-4469	Xarelto	rivaroxaban
50458-575	Xarelto	rivaroxaban
50458-577	XARELTO	rivaroxaban
50458-578	Xarelto	rivaroxaban
50458-579	Xarelto	rivaroxaban
50458-580	Xarelto	Xarelto
50458-584	XARELTO	XARELTO
55154-1423	Xarelto	Xarelto
55154-1424	Xarelto	Xarelto
55154-1422	Xarelto	Xarelto