NDC 50090-3625

Xarelto

Rivaroxaban

Xarelto is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Rivaroxaban.

• Product ID: 50090-3625_909ab4d8-0039-4243-9e08-645c15c1a1e5
• NDC: 50090-3625
• 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: A-S Medication Solutions
• 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: 2022-12-31

Packaging

NDC 50090-3625-0

90 TABLET, FILM COATED in 1 BOTTLE (50090-3625-0)

• Marketing Start Date: 2018-10-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-3625-0 [50090362500]

Xarelto TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA022406
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-10-06

Drug Details

Active Ingredients

Ingredient	Strength
RIVAROXABAN	10 mg/1

OpenFDA Data

• SPL SET ID: 7e9ab975-db2f-423c-a089-bc5a73313609
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • 9NDF7JZ4M3

Pharmacological Class

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