FDA.reportPublic FDA data

RIVAROXABAN

Product NDC
46708-346
11-digit product format
467080346
Labeler code
46708
Product ID
46708-346_4b61dc52-0593-4ef0-8246-a82ff6972842
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RIVAROXABAN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210301-001RIVAROXABANRIVAROXABAN2.5MGTABLET / ORALAB2025-05-14
A210301-002RIVAROXABANRIVAROXABAN10MGTABLET / ORALAB2025-05-14
A210301-003RIVAROXABANRIVAROXABAN15MGTABLET / ORALAB2025-05-14
A210301-004RIVAROXABANRIVAROXABAN20MGTABLET / ORALAB2025-05-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A210301-001AB
A210301-002AB
A210301-003AB
A210301-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A210301-001RIVAROXABAN2.5MGTABLET / ORALAB2025-05-14a50c72e98297…
2026-08-01 22:54:322026-06A210301-002RIVAROXABAN10MGTABLET / ORALAB2025-05-14a50c72e98297…
2026-08-01 22:54:322026-06A210301-003RIVAROXABAN15MGTABLET / ORALAB2025-05-14a50c72e98297…
2026-08-01 22:54:322026-06A210301-004RIVAROXABAN20MGTABLET / ORALAB2025-05-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A210301-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A210301-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A210301-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A210301-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RIVAROXABANRIVAROXABANAlembic Pharmaceuticals Inc.e62f23c6-89f2-4179-95dc-5732401b3f932026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210301
application number: ANDA210301
RIVAROXABANRIVAROXABANAlembic Pharmaceuticals Limited5524f30f-789d-4f5c-8f7c-d03a475b6d342025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210301
application number: ANDA210301
ndc (product): 46708-346

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9NDF7JZ4M3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1114198Internal RxNorm lookup
1232082Internal RxNorm lookup
1232086Internal RxNorm lookup
1549682Internal RxNorm lookup
2059015Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5524f30f-789d-4f5c-8f7c-d03a475b6d34Available on FDA.report

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
46708-346-10RIVAROXABAN10 in 1 BLISTER PACKTABLET, FILM COATED102
46708-346-10RIVAROXABAN100 in 1 CARTONTABLET, FILM COATED1002
46708-346-30RIVAROXABAN30 in 1 BOTTLETABLET, FILM COATED302
46708-346-90RIVAROXABAN90 in 1 BOTTLETABLET, FILM COATED902
46708-346-91RIVAROXABAN1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-346RIVAROXABAN TABLET, FILM COATED RIVAROXABAN KIT [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 5 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
46708-346-1046708034610100 BLISTER PACK in 1 CARTON (46708-346-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2025-05-14NoNoCurrent
46708-346-304670803463030 TABLET, FILM COATED in 1 BOTTLE (46708-346-30) 2025-05-14NoNoCurrent
46708-346-904670803469090 TABLET, FILM COATED in 1 BOTTLE (46708-346-90) 2025-05-14NoNoCurrent
46708-346-91467080346911000 TABLET, FILM COATED in 1 BOTTLE (46708-346-91) 2025-05-14NoNoCurrent