Rivaroxaban

Product NDC: 60505-6256
11-digit product format: 605056256
Labeler code: 60505
Product ID: 60505-6256_0e1a0098-1b42-db14-8e0f-23c8ee1e35cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rivaroxaban
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA217810
Marketing category: ANDA
Marketing start: 2025-05-02
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 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217810-001	RIVAROXABAN	RIVAROXABAN	2.5MG	TABLET / ORAL	AB		2025-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217810-001	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A217810-001	RIVAROXABAN	2.5MG	TABLET / ORAL	AB	2025-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217810-001	RIVAROXABAN	2.5MG	TABLET / ORAL	AB	2025-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217810-001	RIVAROXABAN	2.5MG	TABLET / ORAL	AB	2025-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217810-001	RIVAROXABAN	2.5MG	TABLET / ORAL	AB	2025-05-02	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217810-001	RIVAROXABAN	2.5MG	TABLET / ORAL	AB	2025-05-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A217810-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217810-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217810-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217810-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217810-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Rivaroxaban
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RIVAROXABAN	2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9NDF7JZ4M3	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2059015	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e98f6d83-5172-97a1-ee41-5d7d1d8ba2fd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6cd5c957-f63d-4ae5-a5e5-4e6830870998	Product name	3	20251209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60505-6256-5	Rivaroxaban	500 in 1 BOTTLE	TABLET, FILM COATED	500		3
60505-6256-6	Rivaroxaban	60 in 1 BOTTLE	TABLET, FILM COATED	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-6256-6	EA - Each	60505-6256	4c173a79-f088-49ae-99a2-100d818f7da4	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-6256	RIVAROXABAN TABLET, FILM COATED [APOTEX CORP.]	1	Current NDC, 2 package rows	20250503_e98f6d83-5172-97a1-ee41-5d7d1d8ba2fd.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rivaroxaban	RIVAROXABAN	Apotex Corp.	e98f6d83-5172-97a1-ee41-5d7d1d8ba2fd	2026-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217810 application number: ANDA217810 ndc (product): 60505-6256

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9NDF7JZ4M3	RIVAROXABAN	366789-02-8	RIVAROXABAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2059015	rivaroxaban 2.5 MG Oral Tablet	PSN	e98f6d83-5172-97a1-ee41-5d7d1d8ba2fd	3
2059015	rivaroxaban 2.5 MG Oral Tablet	SCD	e98f6d83-5172-97a1-ee41-5d7d1d8ba2fd	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
60505-6256-5	60505625605	500 TABLET, FILM COATED in 1 BOTTLE (60505-6256-5)	2025-05-02	No	No	Current
60505-6256-6	60505625606	60 TABLET, FILM COATED in 1 BOTTLE (60505-6256-6)	2025-05-02	No	No	Current