FDA.reportPublic FDA data

RIVAROXABAN

Product NDC
31722-496
11-digit product format
317220496
Labeler code
31722
Product ID
31722-496_d1afd534-ca74-462d-9cbb-03e54547cd9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RIVAROXABAN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA219332
Marketing category
ANDA
Marketing start
2025-05-20
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
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
A219332-001RIVAROXABANRIVAROXABAN2.5MGTABLET / ORALAB2025-05-14
A219332-002RIVAROXABANRIVAROXABAN10MGTABLET / ORALAB2025-05-14
A219332-003RIVAROXABANRIVAROXABAN15MGTABLET / ORALAB2025-05-14
A219332-004RIVAROXABANRIVAROXABAN20MGTABLET / 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
A219332-001AB
A219332-002AB
A219332-003AB
A219332-004AB

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 22:54:322026-06A219332-001RIVAROXABAN2.5MGTABLET / ORALAB2025-05-14a50c72e98297…
2026-08-01 22:54:322026-06A219332-002RIVAROXABAN10MGTABLET / ORALAB2025-05-14a50c72e98297…
2026-08-01 22:54:322026-06A219332-003RIVAROXABAN15MGTABLET / ORALAB2025-05-14a50c72e98297…
2026-08-01 22:54:322026-06A219332-004RIVAROXABAN20MGTABLET / ORALAB2025-05-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A219332-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A219332-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A219332-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A219332-004AB1a50c72e98297…

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
RIVAROXABANRIVAROXABANXLCare Pharmaceuticals, Inc.291011aa-60eb-4109-b59c-1c521fbeac4f2025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219332
application number: ANDA219332
RIVAROXABANRIVAROXABANCamber Pharmaceuticals, Inc.45f16f1b-e405-4aa6-bc8b-977d4864af3e2025-05-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219332
application number: ANDA219332
ndc (product): 31722-496

Additional Listing Data#

Finished product
Yes
Brand name base
RIVAROXABAN
Listing expiration
2026-12-31

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
45f16f1b-e405-4aa6-bc8b-977d4864af3eAvailable 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
31722-496-18RIVAROXABAN180 in 1 BOTTLETABLET, FILM COATED1801
31722-496-60RIVAROXABAN60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-496-18EA - Each31722-496c39e1e3e-9b4c-48be-9fa5-67b0979f4d7512025-06-13
31722-496-60EA - Each31722-4963b804b75-85a4-457c-8d92-7aa376aac91f12025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-496RIVAROXABAN TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20250521_45f16f1b-e405-4aa6-bc8b-977d4864af3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2059015rivaroxaban 2.5 MG Oral TabletPSN45f16f1b-e405-4aa6-bc8b-977d4864af3e1
2059015rivaroxaban 2.5 MG Oral TabletSCD45f16f1b-e405-4aa6-bc8b-977d4864af3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-496-1831722049618180 TABLET, FILM COATED in 1 BOTTLE (31722-496-18) 2025-05-20NoNoCurrent
31722-496-603172204966060 TABLET, FILM COATED in 1 BOTTLE (31722-496-60) 2025-05-20NoNoCurrent