FDA.reportPublic FDA data

Rivaroxaban

Product NDC
59651-849
11-digit product format
596510849
Labeler code
59651
Product ID
59651-849_41ba542b-b8da-4a6e-a39e-284fd6314627
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivaroxaban
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA208544
Marketing category
ANDA
Marketing start
2025-04-10
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
2027-12-31
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
A208544-001RIVAROXABANRIVAROXABAN2.5MGTABLET / ORALAB2025-04-10
A208544-002RIVAROXABANRIVAROXABAN10MGTABLET / ORALAB2025-05-15
A208544-003RIVAROXABANRIVAROXABAN15MGTABLET / ORALAB2025-05-15
A208544-004RIVAROXABANRIVAROXABAN20MGTABLET / ORALAB2025-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208544-001AB
A208544-002AB
A208544-003AB
A208544-004AB

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 22:54:322026-06A208544-001RIVAROXABAN2.5MGTABLET / ORALAB2025-04-10a50c72e98297…
2026-08-01 22:54:322026-06A208544-002RIVAROXABAN10MGTABLET / ORALAB2025-05-15a50c72e98297…
2026-08-01 22:54:322026-06A208544-003RIVAROXABAN15MGTABLET / ORALAB2025-05-15a50c72e98297…
2026-08-01 22:54:322026-06A208544-004RIVAROXABAN20MGTABLET / ORALAB2025-05-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208544-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208544-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A208544-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A208544-004AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RivaroxabanRIVAROXABANAurobindo Pharma Limitedbcb0e6e7-3006-4d82-8009-c5fddbbfc80d2026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208544
application number: ANDA208544
ndc (product): 59651-849

Additional Listing Data#

Finished product
Yes
Brand name base
Rivaroxaban
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RIVAROXABAN2.5 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
bcb0e6e7-3006-4d82-8009-c5fddbbfc80dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cd5c957-f63d-4ae5-a5e5-4e6830870998Product name320251209
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-849-18Rivaroxaban180 in 1 BOTTLETABLET, FILM COATED1805
59651-849-60Rivaroxaban60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-849-18EA - Each59651-849837fb0f1-1b4f-4924-9ad2-f30adf5da6f312025-05-14
59651-849-60EA - Each59651-849b1c85e8f-6a9c-461f-8a95-b039dca9a12e12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-849RIVAROXABAN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2Current NDC, 2 package rows20250426_bcb0e6e7-3006-4d82-8009-c5fddbbfc80d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2059015rivaroxaban 2.5 MG Oral TabletPSNbcb0e6e7-3006-4d82-8009-c5fddbbfc80d5
2059015rivaroxaban 2.5 MG Oral TabletSCDbcb0e6e7-3006-4d82-8009-c5fddbbfc80d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59651-849-1859651084918180 TABLET, FILM COATED in 1 BOTTLE (59651-849-18) 2025-04-10NoNoCurrent
59651-849-605965108496060 TABLET, FILM COATED in 1 BOTTLE (59651-849-60) 2025-04-10NoNoCurrent