FDA.reportPublic FDA data

RIVAROXABAN

Product NDC
31722-496
11-digit product format
317220496
Labeler code
31722
Product ID
31722-496_d1afd534-ca74-462d-9cbb-03e54547cd9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RIVAROXABAN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA219332
Marketing category
ANDA
Marketing start
2025-05-20
Substance
RIVAROXABAN
Active strength
2.5 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
RIVAROXABAN2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9NDF7JZ4M3
Rxcui2059015

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
31722-496-18RIVAROXABAN180 in 1 BOTTLETABLET, FILM COATED1801
31722-496-60RIVAROXABAN60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-496-18EA - Each31722-496c39e1e3e-9b4c-48be-9fa5-67b0979f4d7512025-06-13
31722-496-60EA - Each31722-4963b804b75-85a4-457c-8d92-7aa376aac91f12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-496RIVAROXABAN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20250521_45f16f1b-e405-4aa6-bc8b-977d4864af3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2059015rivaroxaban 2.5 MG Oral TabletPSN45f16f1b-e405-4aa6-bc8b-977d4864af3e1
2059015rivaroxaban 2.5 MG Oral TabletSCD45f16f1b-e405-4aa6-bc8b-977d4864af3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-496-1831722049618180 TABLET, FILM COATED in 1 BOTTLE (31722-496-18) 2025-05-20NoNoHistorical
31722-496-603172204966060 TABLET, FILM COATED in 1 BOTTLE (31722-496-60) 2025-05-20NoNoHistorical