RIVAROXABAN

Product NDC
62332-240
11-digit product format
623320240
Labeler code
62332
Product ID
62332-240_43438909-74d8-4b11-b947-00d06de77c88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RIVAROXABAN
Dosage form
KIT
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA210301
Marketing category
ANDA
Marketing start
2025-05-14
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210301-001RIVAROXABANRIVAROXABAN2.5MGTABLET / ORALAB2025-05-14
A210301-002RIVAROXABANRIVAROXABAN10MGTABLET / ORALAB2025-05-14
A210301-003RIVAROXABANRIVAROXABAN15MGTABLET / ORALAB2025-05-14
A210301-004RIVAROXABANRIVAROXABAN20MGTABLET / 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
A210301-001AB
A210301-002AB
A210301-003AB
A210301-004AB

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
2026-08-18 06:07:402026-07A210301-001RIVAROXABAN2.5MGTABLET / ORALAB2025-05-14caaa826d4ba7…
2026-08-18 06:07:402026-07A210301-002RIVAROXABAN10MGTABLET / ORALAB2025-05-14caaa826d4ba7…
2026-08-18 06:07:402026-07A210301-003RIVAROXABAN15MGTABLET / ORALAB2025-05-14caaa826d4ba7…
2026-08-18 06:07:402026-07A210301-004RIVAROXABAN20MGTABLET / ORALAB2025-05-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210301-001RIVAROXABAN2.5MGTABLET / ORALAB2025-05-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210301-002RIVAROXABAN10MGTABLET / ORALAB2025-05-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210301-003RIVAROXABAN15MGTABLET / ORALAB2025-05-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210301-004RIVAROXABAN20MGTABLET / ORALAB2025-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210301-001RIVAROXABAN2.5MGTABLET / ORALAB2025-05-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210301-002RIVAROXABAN10MGTABLET / ORALAB2025-05-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210301-003RIVAROXABAN15MGTABLET / ORALAB2025-05-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210301-004RIVAROXABAN20MGTABLET / ORALAB2025-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A210301-001RIVAROXABAN2.5MGTABLET / ORALAB2025-05-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210301-002RIVAROXABAN10MGTABLET / ORALAB2025-05-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210301-003RIVAROXABAN15MGTABLET / ORALAB2025-05-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210301-004RIVAROXABAN20MGTABLET / ORALAB2025-05-146a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210301-001RIVAROXABAN2.5MGTABLET / ORALAB2025-05-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210301-002RIVAROXABAN10MGTABLET / ORALAB2025-05-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210301-003RIVAROXABAN15MGTABLET / ORALAB2025-05-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210301-004RIVAROXABAN20MGTABLET / ORALAB2025-05-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210301-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210301-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210301-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210301-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210301-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210301-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210301-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210301-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210301-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210301-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210301-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210301-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210301-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210301-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210301-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210301-004AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210301-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210301-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210301-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210301-004AB1a50c72e98297…

Additional Listing Data#

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

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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1114198Internal RxNorm lookup
1232082Internal RxNorm lookup
1232086Internal RxNorm lookup
1549682Internal 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
e62f23c6-89f2-4179-95dc-5732401b3f93Available 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
62332-240-51RIVAROXABAN1 in 1 CARTONKIT17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-240RIVAROXABAN TABLET, FILM COATED RIVAROXABAN KIT [ALEMBIC PHARMACEUTICALS INC.]5Current NDC, 1 package rows20250519_e62f23c6-89f2-4179-95dc-5732401b3f93.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RIVAROXABANRIVAROXABANAlembic Pharmaceuticals Inc.e62f23c6-89f2-4179-95dc-5732401b3f932026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210301
application number: ANDA210301
ndc (product): 62332-240
RIVAROXABANRIVAROXABANAlembic Pharmaceuticals Limited5524f30f-789d-4f5c-8f7c-d03a475b6d342025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210301
application number: ANDA210301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1549682{42 (rivaroxaban 15 MG Oral Tablet) / 9 (rivaroxaban 20 MG Oral Tablet) } PackGPCKe62f23c6-89f2-4179-95dc-5732401b3f937
1114198rivaroxaban 10 MG Oral TabletPSNe62f23c6-89f2-4179-95dc-5732401b3f937
1232082rivaroxaban 15 MG Oral TabletPSNe62f23c6-89f2-4179-95dc-5732401b3f937
2059015rivaroxaban 2.5 MG Oral TabletPSNe62f23c6-89f2-4179-95dc-5732401b3f937
1232086rivaroxaban 20 MG Oral TabletPSNe62f23c6-89f2-4179-95dc-5732401b3f937
1549682rivaroxaban 30-Day Starter Pack (42-15 MG Oral Tablets & 9-20 MG Oral Tablets)PSNe62f23c6-89f2-4179-95dc-5732401b3f937
1114198rivaroxaban 10 MG Oral TabletSCDe62f23c6-89f2-4179-95dc-5732401b3f937
1232082rivaroxaban 15 MG Oral TabletSCDe62f23c6-89f2-4179-95dc-5732401b3f937
2059015rivaroxaban 2.5 MG Oral TabletSCDe62f23c6-89f2-4179-95dc-5732401b3f937
1232086rivaroxaban 20 MG Oral TabletSCDe62f23c6-89f2-4179-95dc-5732401b3f937
1549682rivaroxaban 30-Day Starter Pack (42-15 MG Oral Tablets & 9-20 MG Oral Tablets)SYe62f23c6-89f2-4179-95dc-5732401b3f937

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62332-240-51623320240511 KIT in 1 CARTON (62332-240-51) * 42 TABLET, FILM COATED in 1 BLISTER PACK * 9 TABLET, FILM COATED in 1 BLISTER PACK1 kit2025-05-14NoNoCurrent