FDA.reportPublic FDA data

Rivaroxaban

Product NDC
43598-981
11-digit product format
435980981
Labeler code
43598
Product ID
43598-981_eafdf7d8-5014-31c8-daa1-09fc017f5018
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivaroxaban
Dosage form
TABLET
Route
ORAL
Labeler
Dr.Reddy's Laboratories, Inc.
Application
ANDA208534
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
A208534-001RIVAROXABANRIVAROXABAN2.5MGTABLET / ORALAB2025-05-14
A208534-002RIVAROXABANRIVAROXABAN10MGTABLET / ORALAB2025-05-14
A208534-003RIVAROXABANRIVAROXABAN15MGTABLET / ORALAB2025-05-14
A208534-004RIVAROXABANRIVAROXABAN20MGTABLET / 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
A208534-001AB
A208534-002AB
A208534-003AB
A208534-004AB

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 22:54:322026-06A208534-001RIVAROXABAN2.5MGTABLET / ORALAB2025-05-14a50c72e98297…
2026-08-01 22:54:322026-06A208534-002RIVAROXABAN10MGTABLET / ORALAB2025-05-14a50c72e98297…
2026-08-01 22:54:322026-06A208534-003RIVAROXABAN15MGTABLET / ORALAB2025-05-14a50c72e98297…
2026-08-01 22:54:322026-06A208534-004RIVAROXABAN20MGTABLET / ORALAB2025-05-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208534-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208534-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A208534-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A208534-004AB1a50c72e98297…

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
RivaroxabanRIVAROXABANDr.Reddy's Laboratories, Inc.122e6f78-067b-9065-adb2-ec7fec9f008e2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208534
application number: ANDA208534
ndc (product): 43598-981

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
122e6f78-067b-9065-adb2-ec7fec9f008eAvailable 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
43598-981-18Rivaroxaban180 in 1 BOTTLETABLET18011
43598-981-60Rivaroxaban60 in 1 BOTTLETABLET6011
43598-981-78Rivaroxaban10 in 1 CARTONTABLET1011
43598-981-79Rivaroxaban10 in 1 BLISTER PACKTABLET1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-981-18EA - Each43598-981bf57701e-24b8-4e5a-af0e-4a878f13e7b812025-06-13
43598-981-60EA - Each43598-98101a4d7e7-5f4d-48b9-97bc-421ae341e3e812025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-981RIVAROXABAN TABLET [DR.REDDY'S LABORATORIES, INC.]9Current NDC, 4 package rows20250515_122e6f78-067b-9065-adb2-ec7fec9f008e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2059015rivaroxaban 2.5 MG Oral TabletPSN122e6f78-067b-9065-adb2-ec7fec9f008e11
2059015rivaroxaban 2.5 MG Oral TabletSCD122e6f78-067b-9065-adb2-ec7fec9f008e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-981-1843598098118180 TABLET in 1 BOTTLE (43598-981-18) 180 tablet2025-05-14NoNoCurrent
43598-981-604359809816060 TABLET in 1 BOTTLE (43598-981-60) 60 tablet2025-05-14NoNoCurrent
43598-981-784359809817810 BLISTER PACK in 1 CARTON (43598-981-78) / 10 TABLET in 1 BLISTER PACK (43598-981-79) 10 blister pack2025-05-14NoNoCurrent
43598-981-794359809817910 in 1 BLISTER PACKHistorical