Home DailyMed 75f7a03f-e99c-4e0d-9e25-e899731889fc National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:04:18 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 RLD / RS Approval date N022406-001 XARELTO RIVAROXABAN 10MG TABLET / ORAL AB RLD 2011-07-01 N022406-002 XARELTO RIVAROXABAN 15MG TABLET / ORAL AB RLD 2011-11-04 N022406-003 XARELTO RIVAROXABAN 20MG TABLET / ORAL AB RLD, RS 2011-11-04 N022406-004 XARELTO RIVAROXABAN 2.5MG TABLET / ORAL AB RLD 2018-10-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 13 matching rows.
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.
Product history page 1 of 5 · 176 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N022406-001 XARELTO 10MG TABLET / ORAL AB RLD 2011-07-01 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022406-002 XARELTO 15MG TABLET / ORAL AB RLD 2011-11-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022406-003 XARELTO 20MG TABLET / ORAL AB RLD, RS 2011-11-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N022406-004 XARELTO 2.5MG TABLET / ORAL AB RLD 2018-10-11 c2088c7a36db…2026-09-14 22:38:34 2026-08 N022406-001 XARELTO 10MG TABLET / ORAL AB RLD 2011-07-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022406-002 XARELTO 15MG TABLET / ORAL AB RLD 2011-11-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022406-003 XARELTO 20MG TABLET / ORAL AB RLD, RS 2011-11-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022406-004 XARELTO 2.5MG TABLET / ORAL AB RLD 2018-10-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022406-001 XARELTO 10MG TABLET / ORAL AB RLD 2011-07-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022406-002 XARELTO 15MG TABLET / ORAL AB RLD 2011-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022406-003 XARELTO 20MG TABLET / ORAL AB RLD, RS 2011-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022406-004 XARELTO 2.5MG TABLET / ORAL AB RLD 2018-10-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022406-001 XARELTO 10MG TABLET / ORAL AB RLD 2011-07-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022406-002 XARELTO 15MG TABLET / ORAL AB RLD 2011-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022406-003 XARELTO 20MG TABLET / ORAL AB RLD, RS 2011-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022406-004 XARELTO 2.5MG TABLET / ORAL AB RLD 2018-10-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022406-001 XARELTO 10MG TABLET / ORAL AB RLD 2011-07-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022406-002 XARELTO 15MG TABLET / ORAL AB RLD 2011-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022406-003 XARELTO 20MG TABLET / ORAL AB RLD, RS 2011-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022406-004 XARELTO 2.5MG TABLET / ORAL AB RLD 2018-10-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022406-001 XARELTO 10MG TABLET / ORAL AB RLD 2011-07-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022406-002 XARELTO 15MG TABLET / ORAL AB RLD 2011-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022406-003 XARELTO 20MG TABLET / ORAL AB RLD, RS 2011-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022406-004 XARELTO 2.5MG TABLET / ORAL AB RLD 2018-10-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022406-001 XARELTO 10MG TABLET / ORAL RLD 2011-07-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022406-002 XARELTO 15MG TABLET / ORAL RLD 2011-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022406-003 XARELTO 20MG TABLET / ORAL RLD, RS 2011-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022406-004 XARELTO 2.5MG TABLET / ORAL AB RLD 2018-10-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022406-001 XARELTO 10MG TABLET / ORAL RLD 2011-07-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022406-002 XARELTO 15MG TABLET / ORAL RLD 2011-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022406-003 XARELTO 20MG TABLET / ORAL RLD, RS 2011-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022406-004 XARELTO 2.5MG TABLET / ORAL RLD 2018-10-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022406-001 XARELTO 10MG TABLET / ORAL RLD 2011-07-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022406-002 XARELTO 15MG TABLET / ORAL RLD 2011-11-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022406-003 XARELTO 20MG TABLET / ORAL RLD, RS 2011-11-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022406-004 XARELTO 2.5MG TABLET / ORAL RLD 2018-10-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022406-001 XARELTO 10MG TABLET / ORAL RLD 2011-07-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022406-002 XARELTO 15MG TABLET / ORAL RLD 2011-11-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022406-003 XARELTO 20MG TABLET / ORAL RLD, RS 2011-11-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022406-004 XARELTO 2.5MG TABLET / ORAL RLD 2018-10-11 2680178bc6a6…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 45 · 1,796 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 8 of 12 · 443 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022406-002 M-284 2023-03-10 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022406-002 PED 2023-04-11 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022406-002 PED 2023-09-10 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022406-002 I-867 2024-08-23 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022406-002 PED 2025-02-23 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022406-003 M-284 2023-03-10 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022406-003 PED 2023-04-11 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022406-003 PED 2023-09-10 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022406-003 I-867 2024-08-23 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022406-003 PED 2025-02-23 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022406-004 M-284 2023-03-10 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022406-004 PED 2023-04-11 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022406-004 PED 2023-09-10 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022406-004 I-867 2024-08-23 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022406-004 PED 2025-02-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-001 M-284 2023-03-10 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-001 PED 2023-04-11 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-001 PED 2023-09-10 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-001 I-867 2024-08-23 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-001 PED 2025-02-23 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-002 M-284 2023-03-10 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-002 PED 2023-04-11 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-002 PED 2023-09-10 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-002 I-867 2024-08-23 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-002 PED 2025-02-23 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-003 M-284 2023-03-10 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-003 PED 2023-04-11 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-003 PED 2023-09-10 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-003 I-867 2024-08-23 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-003 PED 2025-02-23 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-004 M-284 2023-03-10 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-004 PED 2023-04-11 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-004 PED 2023-09-10 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-004 I-867 2024-08-23 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022406-004 PED 2025-02-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022406-001 M-284 2023-03-10 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022406-001 PED 2023-04-11 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022406-001 PED 2023-09-10 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022406-001 I-867 2024-08-23 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022406-001 PED 2025-02-23 3f0d92c62455…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.