FDA.reportPublic FDA data

NDC 55154-1423-08 - Xarelto

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
55154-1423
Requested NDC
55154-1423-08
Package NDCs from labels
55154-1423-8, 55154-1423-08
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-08-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Xarelto - Cardinal Health 107, LLCCardinal Health 107, LLC2026-08-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-1423-8Xarelto4440 in 1 BOTTLE, PLASTICTABLET, FILM COATED444027

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-1423XARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]25Current NDC, Legacy NDC, 1 package rows20241122_d0e105f6-28f3-45ee-83bd-7d458835242b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-1423-8EA - Each55154-142378be1f98-564e-4bf4-bd97-c7d23aeb817212024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
rivaroxabanACTIVE INGREDIENT9NDF7JZ4M3XARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH]6
rivaroxabanACTIVE MOIETY9NDF7JZ4M3XARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH]6
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UXARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH]6
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48XARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH]6
ferric oxide redINACTIVE INGREDIENT1K09F3G675XARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH]6
hypromellosesINACTIVE INGREDIENT3NXW29V3WOXARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH]6
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XXARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH]6
magnesium stearateINACTIVE INGREDIENT70097M6I30XARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH]6
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PXARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH]6
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JXARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH]6
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPXARELTO (RIVAROXABAN) TABLET, FILM COATED [CARDINAL HEALTH]6

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 114 · 2,271 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
leader clearlaxPOLYETHYLENE GLYCOL 3350Cardinal Health 110, LLC. dba Leader812c59b0-e7ce-4c7a-91ed-e74b7b1b84be2026-09-22WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350L.N.K. International, Inc.bbc11078-73f7-4d27-b0d3-4d4ae5dae2402026-09-10WarningsExact identifier
unii: G2M7P15E5P
XareltoRIVAROXABANJanssen Pharmaceuticals, Inc.10db92f9-2300-4a80-836b-673e1ae916102026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA022406
ndc (product): 50458-578
ndc (product): 50458-580
ndc (product): 50458-579
rxcui: 2059017
rxcui: 1549683
rxcui: 1114198
rxcui: 1232088
rxcui: 1114202
rxcui: 1232086
rxcui: 2059015
rxcui: 1232084
rxcui: 2588062
rxcui: 2588066
rxcui: 1549682
rxcui: 1232082
spl id: 5294926b-7812-41da-a0e8-56f492198450
spl set id: 10db92f9-2300-4a80-836b-673e1ae91610
unii: 9NDF7JZ4M3
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: 532B59J990
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC7ed915ec-7e99-4e0e-aca0-20718987a88c2026-09-08WarningsExact identifier
unii: G2M7P15E5P
RIVAROXABANRIVAROXABANMicro Labs Limited481b7802-5093-43e7-bbd9-1532197eb6e62026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2059015
unii: 9NDF7JZ4M3
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: 532B59J990
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacyfc3b6006-a75a-41b3-9f0b-a3152df1363f2026-09-04WarningsExact identifier
unii: G2M7P15E5P
basic care clearlaxPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC1ccb8604-34f6-4e1e-beed-eb81d6aa7aef2026-09-03WarningsExact identifier
unii: G2M7P15E5P
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacy006a9eca-400f-47f5-bee5-facf7034043e2026-09-02WarningsExact identifier
unii: G2M7P15E5P
KrogerPOLYETHYLENE GLYCOL 3350KROGER COMPANYc56271ff-703a-40c4-840f-1962798c9e422026-09-02WarningsExact identifier
unii: G2M7P15E5P
gentle laxPOLYETHYLENE GLYCOL 3350Kroger Company0d820dcc-440a-4036-86e9-fdb30cac95732026-09-01WarningsExact identifier
unii: G2M7P15E5P
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLCbd33463b-eb1a-41ed-92d1-f50d0923eb3b2026-08-31WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC4d524ace-9de5-4f62-9263-7cd88a36b67c2026-08-28WarningsExact identifier
unii: G2M7P15E5P
PEG3350POLYETHYLENE GLYCOL 3350Major Pharmaceuticals161629f6-6193-4712-bba7-7d5b174a93382026-08-28WarningsExact identifier
unii: G2M7P15E5P
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
Mix-In Laxative PacketsPOLYETHYLENE GLYCOL 3350Wal-Mart Stores Inc0347c934-1e85-4f8d-8d35-bb07f16810ad2026-08-27WarningsExact identifier
unii: G2M7P15E5P

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.