Rivaroxaban

Product NDC
67877-882
11-digit product format
678770882
Labeler code
67877
Product ID
67877-882_d111f8d6-a073-4a43-bf16-bc1bacba9898
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivaroxaban
Dosage form
GRANULE, FOR SUSPENSION
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA218502
Marketing category
ANDA
Marketing start
2025-07-07
Substance
RIVAROXABAN
Active strength
155 mg/1
Pharmacologic classes
Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rivaroxaban
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIVAROXABAN155 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9NDF7JZ4M3
Rxcui2588062

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cd5c957-f63d-4ae5-a5e5-4e6830870998Product name320251209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-882-71Rivaroxaban1 in 1 BOTTLEGRANULE, FOR SUSPENSION15
67877-882-71Rivaroxaban1 in 1 CARTONGRANULE, FOR SUSPENSION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-882-71ML - Milliliter67877-882c98691b7-28b5-4431-ac46-c6974337f5e212025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2588062rivaroxaban 1 MG/mL Oral SuspensionPSNc0efa9f9-ca7a-471a-8030-99056fa5da095
2588062rivaroxaban 1 MG/ML Oral SuspensionSCDc0efa9f9-ca7a-471a-8030-99056fa5da095

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67877-882-71678770882711 BOTTLE in 1 CARTON (67877-882-71) / 1 GRANULE, FOR SUSPENSION in 1 BOTTLE1 bottle2025-07-07NoNoHistorical