FDA.reportPublic FDA data

RIVAROXABAN

Product NDC
68180-709
11-digit product format
681800709
Labeler code
68180
Product ID
68180-709_310f0bf6-9b0f-441b-afd7-b9a0f7905395
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RIVAROXABAN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA208555
Marketing category
ANDA
Marketing start
2025-03-06
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
A208555-001RIVAROXABANRIVAROXABAN2.5MGTABLET / ORALAB2025-03-03
A208555-002RIVAROXABANRIVAROXABAN10MGTABLET / ORALAB2025-05-14
A208555-003RIVAROXABANRIVAROXABAN15MGTABLET / ORALAB2025-05-14
A208555-004RIVAROXABANRIVAROXABAN20MGTABLET / 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
A208555-001AB
A208555-002AB
A208555-003AB
A208555-004AB

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 22:54:322026-06A208555-001RIVAROXABAN2.5MGTABLET / ORALAB2025-03-03a50c72e98297…
2026-08-01 22:54:322026-06A208555-002RIVAROXABAN10MGTABLET / ORALAB2025-05-14a50c72e98297…
2026-08-01 22:54:322026-06A208555-003RIVAROXABAN15MGTABLET / ORALAB2025-05-14a50c72e98297…
2026-08-01 22:54:322026-06A208555-004RIVAROXABAN20MGTABLET / ORALAB2025-05-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A208555-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A208555-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A208555-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A208555-004AB1a50c72e98297…

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
RIVAROXABANRIVAROXABANLupin Pharmaceuticals, Inc.702fed3e-ae25-49ba-98cc-562e0e2442142026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208555
application number: ANDA208555
ndc (product): 68180-709

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
702fed3e-ae25-49ba-98cc-562e0e244214Available 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
68180-709-06RIVAROXABAN30 in 1 BOTTLETABLET, FILM COATED3014
68180-709-09RIVAROXABAN90 in 1 BOTTLETABLET, FILM COATED9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-709-06EA - Each68180-7095b468a71-95e1-4e77-add7-aacc63e9770f12025-05-14
68180-709-09EA - Each68180-709785768ef-6ca0-4834-a4c1-703c286c2ba612025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-709RIVAROXABAN TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.]11Current NDC, 2 package rows20250309_702fed3e-ae25-49ba-98cc-562e0e244214.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2059015rivaroxaban 2.5 MG Oral TabletPSN702fed3e-ae25-49ba-98cc-562e0e24421414
2059015rivaroxaban 2.5 MG Oral TabletSCD702fed3e-ae25-49ba-98cc-562e0e24421414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68180-709-066818007090630 TABLET, FILM COATED in 1 BOTTLE (68180-709-06) 2025-03-06NoNoCurrent
68180-709-096818007090990 TABLET, FILM COATED in 1 BOTTLE (68180-709-09) 2025-03-06NoNoCurrent