FDA.reportPublic FDA data

RIVAROXABAN

Product NDC
62332-346
11-digit product format
623320346
Labeler code
62332
Product ID
62332-346_43438909-74d8-4b11-b947-00d06de77c88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RIVAROXABAN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA210301
Marketing category
ANDA
Marketing start
2025-05-14
Substance
RIVAROXABAN
Active strength
10 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
RIVAROXABAN10 mg/1

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
62332-346-10RIVAROXABAN100 in 1 CARTONTABLET, FILM COATED1007
62332-346-10RIVAROXABAN10 in 1 BLISTER PACKTABLET, FILM COATED107
62332-346-30RIVAROXABAN30 in 1 BOTTLETABLET, FILM COATED307
62332-346-90RIVAROXABAN90 in 1 BOTTLETABLET, FILM COATED907
62332-346-91RIVAROXABAN1000 in 1 BOTTLETABLET, FILM COATED10007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-346RIVAROXABAN TABLET, FILM COATED RIVAROXABAN KIT [ALEMBIC PHARMACEUTICALS INC.]5Current NDC, 5 package rows20250519_e62f23c6-89f2-4179-95dc-5732401b3f93.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) } PackGPCKe62f23c6-89f2-4179-95dc-5732401b3f937
1114198rivaroxaban 10 MG Oral TabletPSNe62f23c6-89f2-4179-95dc-5732401b3f937
1232082rivaroxaban 15 MG Oral TabletPSNe62f23c6-89f2-4179-95dc-5732401b3f937
2059015rivaroxaban 2.5 MG Oral TabletPSNe62f23c6-89f2-4179-95dc-5732401b3f937
1232086rivaroxaban 20 MG Oral TabletPSNe62f23c6-89f2-4179-95dc-5732401b3f937
1549682rivaroxaban 30-Day Starter Pack (42-15 MG Oral Tablets & 9-20 MG Oral Tablets)PSNe62f23c6-89f2-4179-95dc-5732401b3f937
1114198rivaroxaban 10 MG Oral TabletSCDe62f23c6-89f2-4179-95dc-5732401b3f937
1232082rivaroxaban 15 MG Oral TabletSCDe62f23c6-89f2-4179-95dc-5732401b3f937
2059015rivaroxaban 2.5 MG Oral TabletSCDe62f23c6-89f2-4179-95dc-5732401b3f937
1232086rivaroxaban 20 MG Oral TabletSCDe62f23c6-89f2-4179-95dc-5732401b3f937
1549682rivaroxaban 30-Day Starter Pack (42-15 MG Oral Tablets & 9-20 MG Oral Tablets)SYe62f23c6-89f2-4179-95dc-5732401b3f937

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62332-346-1062332034610100 BLISTER PACK in 1 CARTON (62332-346-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2025-05-14NoNoCurrent
62332-346-306233203463030 TABLET, FILM COATED in 1 BOTTLE (62332-346-30) 2025-05-14NoNoCurrent
62332-346-906233203469090 TABLET, FILM COATED in 1 BOTTLE (62332-346-90) 2025-05-14NoNoCurrent
62332-346-91623320346911000 TABLET, FILM COATED in 1 BOTTLE (62332-346-91) 2025-05-14NoNoCurrent