FDA.reportPublic FDA data

Rivaroxaban

Product NDC
33342-488
11-digit product format
333420488
Labeler code
33342
Product ID
33342-488_b6691115-e5df-4846-8358-79d091cdc3c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivaroxaban
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA213114
Marketing category
ANDA
Marketing start
2025-05-14
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
A213114-001RIVAROXABANRIVAROXABAN2.5MGTABLET / ORALAB2025-05-14
A213114-002RIVAROXABANRIVAROXABAN10MGTABLET / ORALAB2025-05-14
A213114-003RIVAROXABANRIVAROXABAN15MGTABLET / ORALAB2025-05-14
A213114-004RIVAROXABANRIVAROXABAN20MGTABLET / 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
A213114-001AB
A213114-002AB
A213114-003AB
A213114-004AB

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 22:54:322026-06A213114-001RIVAROXABAN2.5MGTABLET / ORALAB2025-05-14a50c72e98297…
2026-08-01 22:54:322026-06A213114-002RIVAROXABAN10MGTABLET / ORALAB2025-05-14a50c72e98297…
2026-08-01 22:54:322026-06A213114-003RIVAROXABAN15MGTABLET / ORALAB2025-05-14a50c72e98297…
2026-08-01 22:54:322026-06A213114-004RIVAROXABAN20MGTABLET / ORALAB2025-05-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213114-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A213114-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A213114-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A213114-004AB1a50c72e98297…

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
RivaroxabanRIVAROXABANNorthStar RxLLC88246a0e-befe-4dc6-81e1-4b7adc266db22026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213114
application number: ANDA213114
RivaroxabanRIVAROXABANMacleods Pharmaceuticals Limited57717a31-d9d3-4246-90c0-4e4c0a29adf52026-04-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213114
application number: ANDA213114
ndc (product): 33342-488

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
57717a31-d9d3-4246-90c0-4e4c0a29adf5Available 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
33342-488-09Rivaroxaban60 in 1 BOTTLETABLET, FILM COATED604
33342-488-57Rivaroxaban180 in 1 BOTTLETABLET, FILM COATED1804
33342-488-98Rivaroxaban10 in 1 CARTONTABLET, FILM COATED104
33342-488-98Rivaroxaban6 in 1 BLISTER PACKTABLET, FILM COATED64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-488-09EA - Each33342-48823337fc5-55ad-47d5-b169-c971e9c8b01f12025-06-13
33342-488-57EA - Each33342-488608871e9-0e07-40d5-a93b-1524871c3ac812025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-488RIVAROXABAN TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]2Current NDC, 4 package rows20250522_57717a31-d9d3-4246-90c0-4e4c0a29adf5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2059015rivaroxaban 2.5 MG Oral TabletPSN57717a31-d9d3-4246-90c0-4e4c0a29adf54
2059015rivaroxaban 2.5 MG Oral TabletSCD57717a31-d9d3-4246-90c0-4e4c0a29adf54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-488-093334204880960 TABLET, FILM COATED in 1 BOTTLE (33342-488-09) 2025-05-14NoNoCurrent
33342-488-5733342048857180 TABLET, FILM COATED in 1 BOTTLE (33342-488-57) 2025-05-14NoNoCurrent
33342-488-983334204889810 BLISTER PACK in 1 CARTON (33342-488-98) / 6 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2025-05-14NoNoCurrent