rivaroxaban

Product NDC: 55488-0541
11-digit product format: 554880541
Labeler code: 55488
Product ID: 55488-0541_8b1205ed-1f1c-4e13-8076-aefada9213ad
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rivaroxaban
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Changzhou Pharmaceutical Factory
Application: ANDA216995
Marketing category: ANDA
Marketing start: 2026-02-01
Substance: RIVAROXABAN
Active strength: 15 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A216995-001	RIVAROXABAN	RIVAROXABAN	10MG	TABLET / ORAL	AB	2025-05-14
A216995-002	RIVAROXABAN	RIVAROXABAN	15MG	TABLET / ORAL	AB	2025-05-14
A216995-003	RIVAROXABAN	RIVAROXABAN	20MG	TABLET / ORAL	AB	2025-05-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A216995-001	AB
A216995-002	AB
A216995-003	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	A216995-001	RIVAROXABAN	10MG	TABLET / ORAL	AB	2025-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216995-002	RIVAROXABAN	15MG	TABLET / ORAL	AB	2025-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216995-003	RIVAROXABAN	20MG	TABLET / ORAL	AB	2025-05-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216995-001	RIVAROXABAN	10MG	TABLET / ORAL	AB	2025-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216995-002	RIVAROXABAN	15MG	TABLET / ORAL	AB	2025-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216995-003	RIVAROXABAN	20MG	TABLET / ORAL	AB	2025-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216995-001	RIVAROXABAN	10MG	TABLET / ORAL	AB	2025-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216995-002	RIVAROXABAN	15MG	TABLET / ORAL	AB	2025-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216995-003	RIVAROXABAN	20MG	TABLET / ORAL	AB	2025-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216995-001	RIVAROXABAN	10MG	TABLET / ORAL	AB	2025-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216995-002	RIVAROXABAN	15MG	TABLET / ORAL	AB	2025-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216995-003	RIVAROXABAN	20MG	TABLET / ORAL	AB	2025-05-14	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216995-001	RIVAROXABAN	10MG	TABLET / ORAL	AB	2025-05-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216995-002	RIVAROXABAN	15MG	TABLET / ORAL	AB	2025-05-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216995-003	RIVAROXABAN	20MG	TABLET / ORAL	AB	2025-05-14	`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	A216995-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216995-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216995-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216995-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216995-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216995-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216995-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216995-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216995-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216995-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216995-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216995-003	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216995-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216995-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216995-003	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	15 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1114198	Internal RxNorm lookup
1232082	Internal RxNorm lookup
1232086	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
9178947d-9d58-4c1a-b158-6030e17556af	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55488-0541-1	rivaroxaban	30 in 1 BOTTLE	TABLET, FILM COATED	30		3

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	Changzhou Pharmaceutical Factory	9178947d-9d58-4c1a-b158-6030e17556af	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216995 application number: ANDA216995 ndc (product): 55488-0541

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
1114198	rivaroxaban 10 MG Oral Tablet	PSN	9178947d-9d58-4c1a-b158-6030e17556af	3
1232082	rivaroxaban 15 MG Oral Tablet	PSN	9178947d-9d58-4c1a-b158-6030e17556af	3
1232086	rivaroxaban 20 MG Oral Tablet	PSN	9178947d-9d58-4c1a-b158-6030e17556af	3
1114198	rivaroxaban 10 MG Oral Tablet	SCD	9178947d-9d58-4c1a-b158-6030e17556af	3
1232082	rivaroxaban 15 MG Oral Tablet	SCD	9178947d-9d58-4c1a-b158-6030e17556af	3
1232086	rivaroxaban 20 MG Oral Tablet	SCD	9178947d-9d58-4c1a-b158-6030e17556af	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
55488-0541-1	55488054101	30 TABLET, FILM COATED in 1 BOTTLE (55488-0541-1)	2026-02-01	No	No	Current