NDC 55154-1423

Xarelto

Rivaroxaban

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

• Product ID: 55154-1423_39cd791c-ad37-473a-87ab-39ad08ff2c48
• NDC: 55154-1423
• Product Type: Human Prescription Drug
• Proprietary Name: Xarelto
• Generic Name: Rivaroxaban
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2011-11-05
• Marketing Category: NDA / NDA
• Application Number: NDA202439
• Labeler Name: Cardinal Health.
• Substance Name: RIVAROXABAN
• Active Ingredient Strength: 20 mg/1
• Pharm Classes: Factor Xa Inhibitors [MoA],Factor Xa Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55154-1423-8

4440 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-1423-8)

• Marketing Start Date: 2011-11-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55154-1423-8 [55154142308]

Xarelto TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA202439
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-11-05

Drug Details

Active Ingredients

Ingredient	Strength
RIVAROXABAN	20 mg/1

OpenFDA Data

• SPL SET ID: d0e105f6-28f3-45ee-83bd-7d458835242b
• Manufacturer:
  • Cardinal Health.
• UNII:
  • 9NDF7JZ4M3
• RxNorm Concept Unique ID - RxCUI:
  • 1114198
  • 1114202
  • 1232088
  • 1232082
  • 1232084
  • 1232086
• UPC Code:
  • 0055154142205
  • 0055154142403
  • 0355154142381

Pharmacological Class

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

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