FDA.reportPublic FDA data

Rivaroxaban

Product NDC
14445-147
Requested package NDC
14445-147-10
11-digit product format
144450147
Labeler code
14445
Product ID
14445-147_b57414a3-eca8-4cda-b7eb-7c060d52a6b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rivaroxaban
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Indoco Remedies Limited
Application
ANDA218445
Marketing category
ANDA
Marketing start
2025-08-11
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
A218445-001RIVAROXABANRIVAROXABAN2.5MGTABLET / ORALAB2025-08-11
A218445-002RIVAROXABANRIVAROXABAN10MGTABLET / ORALAB2025-08-11
A218445-003RIVAROXABANRIVAROXABAN15MGTABLET / ORALAB2025-08-11
A218445-004RIVAROXABANRIVAROXABAN20MGTABLET / ORALAB2025-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A218445-001AB
A218445-002AB
A218445-003AB
A218445-004AB

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 22:54:322026-06A218445-001RIVAROXABAN2.5MGTABLET / ORALAB2025-08-11a50c72e98297…
2026-08-01 22:54:322026-06A218445-002RIVAROXABAN10MGTABLET / ORALAB2025-08-11a50c72e98297…
2026-08-01 22:54:322026-06A218445-003RIVAROXABAN15MGTABLET / ORALAB2025-08-11a50c72e98297…
2026-08-01 22:54:322026-06A218445-004RIVAROXABAN20MGTABLET / ORALAB2025-08-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A218445-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A218445-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A218445-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A218445-004AB1a50c72e98297…

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
RivaroxabanRIVAROXABANIndoco Remedies Limited9fee7136-c8fd-4bea-ab15-7a0e7292396d2025-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218445
application number: ANDA218445
ndc (package): 14445-147-10
ndc (product): 14445-147
ndc11 (package): 14445014710
rivaroxabanRIVAROXABANFlorida Pharmaceutical Products, LLCf0ef9361-f06d-4028-97af-183b545f4aea2025-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218445
application number: ANDA218445

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1114198Internal RxNorm lookup
1232082Internal RxNorm lookup
1232086Internal RxNorm lookup
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
9fee7136-c8fd-4bea-ab15-7a0e7292396dAvailable 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
14445-147-02Rivaroxaban10 in 1 BLISTER PACKTABLET, FILM COATED102
14445-147-10Rivaroxaban10 in 1 CARTONTABLET, FILM COATED102
14445-147-18Rivaroxaban180 in 1 BOTTLETABLET, FILM COATED1802
14445-147-60Rivaroxaban60 in 1 BOTTLETABLET, FILM COATED602

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1114198rivaroxaban 10 MG Oral TabletPSN9fee7136-c8fd-4bea-ab15-7a0e7292396d2
1232082rivaroxaban 15 MG Oral TabletPSN9fee7136-c8fd-4bea-ab15-7a0e7292396d2
2059015rivaroxaban 2.5 MG Oral TabletPSN9fee7136-c8fd-4bea-ab15-7a0e7292396d2
1232086rivaroxaban 20 MG Oral TabletPSN9fee7136-c8fd-4bea-ab15-7a0e7292396d2
1114198rivaroxaban 10 MG Oral TabletSCD9fee7136-c8fd-4bea-ab15-7a0e7292396d2
1232082rivaroxaban 15 MG Oral TabletSCD9fee7136-c8fd-4bea-ab15-7a0e7292396d2
2059015rivaroxaban 2.5 MG Oral TabletSCD9fee7136-c8fd-4bea-ab15-7a0e7292396d2
1232086rivaroxaban 20 MG Oral TabletSCD9fee7136-c8fd-4bea-ab15-7a0e7292396d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
14445-147-101444501471010 BLISTER PACK in 1 CARTON (14445-147-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK (14445-147-02) 10 blister pack2025-08-11NoNoCurrent