RIVAROXABAN

Product NDC: 46708-346
11-digit product format: 467080346
Labeler code: 46708
Product ID: 46708-346_4b61dc52-0593-4ef0-8246-a82ff6972842
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: RIVAROXABAN
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA210301
Marketing category: ANDA
Marketing start: 2025-05-14
Substance: RIVAROXABAN
Active strength: 10 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 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A210301-001	RIVAROXABAN	RIVAROXABAN	2.5MG	TABLET / ORAL	AB	2025-05-14
A210301-002	RIVAROXABAN	RIVAROXABAN	10MG	TABLET / ORAL	AB	2025-05-14
A210301-003	RIVAROXABAN	RIVAROXABAN	15MG	TABLET / ORAL	AB	2025-05-14
A210301-004	RIVAROXABAN	RIVAROXABAN	20MG	TABLET / ORAL	AB	2025-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210301-001	AB
A210301-002	AB
A210301-003	AB
A210301-004	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	A210301-001	RIVAROXABAN	2.5MG	TABLET / ORAL	AB	2025-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210301-002	RIVAROXABAN	10MG	TABLET / ORAL	AB	2025-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210301-003	RIVAROXABAN	15MG	TABLET / ORAL	AB	2025-05-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210301-004	RIVAROXABAN	20MG	TABLET / ORAL	AB	2025-05-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210301-001	RIVAROXABAN	2.5MG	TABLET / ORAL	AB	2025-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210301-002	RIVAROXABAN	10MG	TABLET / ORAL	AB	2025-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210301-003	RIVAROXABAN	15MG	TABLET / ORAL	AB	2025-05-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210301-004	RIVAROXABAN	20MG	TABLET / ORAL	AB	2025-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210301-001	RIVAROXABAN	2.5MG	TABLET / ORAL	AB	2025-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210301-002	RIVAROXABAN	10MG	TABLET / ORAL	AB	2025-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210301-003	RIVAROXABAN	15MG	TABLET / ORAL	AB	2025-05-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210301-004	RIVAROXABAN	20MG	TABLET / ORAL	AB	2025-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210301-001	RIVAROXABAN	2.5MG	TABLET / ORAL	AB	2025-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210301-002	RIVAROXABAN	10MG	TABLET / ORAL	AB	2025-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210301-003	RIVAROXABAN	15MG	TABLET / ORAL	AB	2025-05-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210301-004	RIVAROXABAN	20MG	TABLET / ORAL	AB	2025-05-14	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210301-001	RIVAROXABAN	2.5MG	TABLET / ORAL	AB	2025-05-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210301-002	RIVAROXABAN	10MG	TABLET / ORAL	AB	2025-05-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210301-003	RIVAROXABAN	15MG	TABLET / ORAL	AB	2025-05-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210301-004	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	A210301-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210301-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210301-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210301-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210301-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210301-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210301-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210301-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210301-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210301-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210301-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210301-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210301-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210301-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210301-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210301-004	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210301-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210301-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210301-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210301-004	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RIVAROXABAN	10 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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1114198	Internal RxNorm lookup
1232082	Internal RxNorm lookup
1232086	Internal RxNorm lookup
1549682	Internal RxNorm lookup
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
5524f30f-789d-4f5c-8f7c-d03a475b6d34	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	SPL version
46708-346-10	RIVAROXABAN	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	2
46708-346-10	RIVAROXABAN	100 in 1 CARTON	TABLET, FILM COATED	100	2
46708-346-30	RIVAROXABAN	30 in 1 BOTTLE	TABLET, FILM COATED	30	2
46708-346-90	RIVAROXABAN	90 in 1 BOTTLE	TABLET, FILM COATED	90	2
46708-346-91	RIVAROXABAN	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-346	RIVAROXABAN TABLET, FILM COATED RIVAROXABAN KIT [ALEMBIC PHARMACEUTICALS LIMITED]	1	Current NDC, 5 package rows	20250523_5524f30f-789d-4f5c-8f7c-d03a475b6d34.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RIVAROXABAN	RIVAROXABAN	Alembic Pharmaceuticals Inc.	e62f23c6-89f2-4179-95dc-5732401b3f93	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210301 application number: ANDA210301
RIVAROXABAN	RIVAROXABAN	Alembic Pharmaceuticals Limited	5524f30f-789d-4f5c-8f7c-d03a475b6d34	2025-11-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210301 application number: ANDA210301 ndc (product): 46708-346

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
1549682	{42 (rivaroxaban 15 MG Oral Tablet) / 9 (rivaroxaban 20 MG Oral Tablet) } Pack	GPCK	5524f30f-789d-4f5c-8f7c-d03a475b6d34	2
1114198	rivaroxaban 10 MG Oral Tablet	PSN	5524f30f-789d-4f5c-8f7c-d03a475b6d34	2
1232082	rivaroxaban 15 MG Oral Tablet	PSN	5524f30f-789d-4f5c-8f7c-d03a475b6d34	2
2059015	rivaroxaban 2.5 MG Oral Tablet	PSN	5524f30f-789d-4f5c-8f7c-d03a475b6d34	2
1232086	rivaroxaban 20 MG Oral Tablet	PSN	5524f30f-789d-4f5c-8f7c-d03a475b6d34	2
1549682	rivaroxaban 30-Day Starter Pack (42-15 MG Oral Tablets & 9-20 MG Oral Tablets)	PSN	5524f30f-789d-4f5c-8f7c-d03a475b6d34	2
1114198	rivaroxaban 10 MG Oral Tablet	SCD	5524f30f-789d-4f5c-8f7c-d03a475b6d34	2
1232082	rivaroxaban 15 MG Oral Tablet	SCD	5524f30f-789d-4f5c-8f7c-d03a475b6d34	2
2059015	rivaroxaban 2.5 MG Oral Tablet	SCD	5524f30f-789d-4f5c-8f7c-d03a475b6d34	2
1232086	rivaroxaban 20 MG Oral Tablet	SCD	5524f30f-789d-4f5c-8f7c-d03a475b6d34	2
1549682	rivaroxaban 30-Day Starter Pack (42-15 MG Oral Tablets & 9-20 MG Oral Tablets)	SY	5524f30f-789d-4f5c-8f7c-d03a475b6d34	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
46708-346-10	46708034610	100 BLISTER PACK in 1 CARTON (46708-346-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK	100 blister pack	2025-05-14	No	No	Current
46708-346-30	46708034630	30 TABLET, FILM COATED in 1 BOTTLE (46708-346-30)		2025-05-14	No	No	Current
46708-346-90	46708034690	90 TABLET, FILM COATED in 1 BOTTLE (46708-346-90)		2025-05-14	No	No	Current
46708-346-91	46708034691	1000 TABLET, FILM COATED in 1 BOTTLE (46708-346-91)		2025-05-14	No	No	Current