RIVAROXABAN

Product NDC
46708-240
11-digit product format
467080240
Labeler code
46708
Product ID
46708-240_4b61dc52-0593-4ef0-8246-a82ff6972842
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RIVAROXABAN
Dosage form
KIT
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA210301
Marketing category
ANDA
Marketing start
2025-05-14
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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9NDF7JZ4M3
Rxcui1114198, 1232082, 1232086, 1549682, 2059015

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
46708-240-51RIVAROXABAN1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-240RIVAROXABAN TABLET, FILM COATED RIVAROXABAN KIT [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 1 package rows20250523_5524f30f-789d-4f5c-8f7c-d03a475b6d34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1549682{42 (rivaroxaban 15 MG Oral Tablet) / 9 (rivaroxaban 20 MG Oral Tablet) } PackGPCK5524f30f-789d-4f5c-8f7c-d03a475b6d342
1114198rivaroxaban 10 MG Oral TabletPSN5524f30f-789d-4f5c-8f7c-d03a475b6d342
1232082rivaroxaban 15 MG Oral TabletPSN5524f30f-789d-4f5c-8f7c-d03a475b6d342
2059015rivaroxaban 2.5 MG Oral TabletPSN5524f30f-789d-4f5c-8f7c-d03a475b6d342
1232086rivaroxaban 20 MG Oral TabletPSN5524f30f-789d-4f5c-8f7c-d03a475b6d342
1549682rivaroxaban 30-Day Starter Pack (42-15 MG Oral Tablets & 9-20 MG Oral Tablets)PSN5524f30f-789d-4f5c-8f7c-d03a475b6d342
1114198rivaroxaban 10 MG Oral TabletSCD5524f30f-789d-4f5c-8f7c-d03a475b6d342
1232082rivaroxaban 15 MG Oral TabletSCD5524f30f-789d-4f5c-8f7c-d03a475b6d342
2059015rivaroxaban 2.5 MG Oral TabletSCD5524f30f-789d-4f5c-8f7c-d03a475b6d342
1232086rivaroxaban 20 MG Oral TabletSCD5524f30f-789d-4f5c-8f7c-d03a475b6d342
1549682rivaroxaban 30-Day Starter Pack (42-15 MG Oral Tablets & 9-20 MG Oral Tablets)SY5524f30f-789d-4f5c-8f7c-d03a475b6d342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-240-51467080240511 KIT in 1 CARTON (46708-240-51) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 9 TABLET, FILM COATED in 1 BLISTER PACK1 kit2025-05-14NoNoCurrent