Home DailyMed de96c081-bebd-451a-9c15-e58c56cf588b 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 2013-02-13
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 03:24:16
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 43 .
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 RLD / RS Approval date N202155-001 ELIQUIS APIXABAN 2.5MG TABLET / ORAL AB RLD 2012-12-28 N202155-002 ELIQUIS APIXABAN 5MG TABLET / ORAL AB RLD, RS 2012-12-28 N202155-003 ELIQUIS APIXABAN 0.5MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2025-04-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 25 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202155-001 6967208 2026-11-21 U-1167 Drug substance, Drug product 2013-01-25 N202155-001 6967208 2026-11-21 U-1200 Drug substance, Drug product 2013-01-25 N202155-001 6967208 2026-11-21 U-1301 Drug substance, Drug product 2013-01-25 N202155-001 6967208 2026-11-21 U-1302 Drug substance, Drug product 2013-01-25 N202155-001 6967208 2026-11-21 U-1323 Drug substance, Drug product 2013-01-25 N202155-001 6967208 2026-11-21 U-1501 Drug substance, Drug product 2013-01-25 N202155-001 6967208 2026-11-21 U-1502 Drug substance, Drug product 2013-01-25 N202155-001 6967208 2026-11-21 U-1729 Drug substance, Drug product 2013-01-25 N202155-001 6967208 2026-11-21 U-1730 Drug substance, Drug product 2013-01-25 N202155-001 6967208 2026-11-21 U-4178 Drug substance, Drug product 2013-01-25 N202155-001 6967208*PED 2027-05-21 Pediatric extension N202155-001 9326945 2031-02-24 Drug product 2016-05-26 N202155-001 9326945*PED 2031-08-24 Pediatric extension N202155-002 6967208 2026-11-21 U-1200 Drug substance, Drug product 2013-01-25 N202155-002 6967208 2026-11-21 U-1301 Drug substance, Drug product 2013-01-25 N202155-002 6967208 2026-11-21 U-1302 Drug substance, Drug product 2013-01-25 N202155-002 6967208 2026-11-21 U-1323 Drug substance, Drug product 2013-01-25 N202155-002 6967208 2026-11-21 U-4178 Drug substance, Drug product 2013-01-25 N202155-002 6967208*PED 2027-05-21 Pediatric extension N202155-002 9326945 2031-02-24 Drug product 2016-05-26 N202155-002 9326945*PED 2031-08-24 Pediatric extension N202155-003 6967208 2026-11-21 U-4179 Drug substance, Drug product 2025-05-16 N202155-003 6967208*PED 2027-05-21 Pediatric extension N202155-003 9326945 2031-02-24 Drug product 2025-05-16 N202155-003 9326945*PED 2031-08-24 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 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 3 · 92 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 2026-09-14 22:38:34 2026-08 N202155-001 ELIQUIS 2.5MG TABLET / ORAL AB RLD 2012-12-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-002 ELIQUIS 5MG TABLET / ORAL AB RLD, RS 2012-12-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-003 ELIQUIS 0.5MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2025-04-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 N202155-001 ELIQUIS 2.5MG TABLET / ORAL AB RLD 2012-12-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202155-002 ELIQUIS 5MG TABLET / ORAL AB RLD, RS 2012-12-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202155-003 ELIQUIS 0.5MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2025-04-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202155-001 ELIQUIS 2.5MG TABLET / ORAL AB RLD 2012-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202155-002 ELIQUIS 5MG TABLET / ORAL AB RLD, RS 2012-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202155-003 ELIQUIS 0.5MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2025-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202155-001 ELIQUIS 2.5MG TABLET / ORAL AB RLD 2012-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202155-002 ELIQUIS 5MG TABLET / ORAL AB RLD, RS 2012-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202155-003 ELIQUIS 0.5MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2025-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202155-001 ELIQUIS 2.5MG TABLET / ORAL AB RLD 2012-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202155-002 ELIQUIS 5MG TABLET / ORAL AB RLD, RS 2012-12-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202155-003 ELIQUIS 0.5MG TABLET, FOR SUSPENSION / ORAL RLD, RS 2025-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202155-001 ELIQUIS 2.5MG TABLET / ORAL AB RLD 2012-12-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202155-002 ELIQUIS 5MG TABLET / ORAL AB RLD, RS 2012-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202155-001 ELIQUIS 2.5MG TABLET / ORAL AB RLD 2012-12-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202155-002 ELIQUIS 5MG TABLET / ORAL AB RLD, RS 2012-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202155-001 ELIQUIS 2.5MG TABLET / ORAL AB RLD 2012-12-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202155-002 ELIQUIS 5MG TABLET / ORAL AB RLD, RS 2012-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202155-001 ELIQUIS 2.5MG TABLET / ORAL AB RLD 2012-12-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202155-002 ELIQUIS 5MG TABLET / ORAL AB RLD, RS 2012-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202155-001 ELIQUIS 2.5MG TABLET / ORAL AB RLD 2012-12-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202155-002 ELIQUIS 5MG TABLET / ORAL AB RLD, RS 2012-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202155-001 ELIQUIS 2.5MG TABLET / ORAL AB RLD 2012-12-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202155-002 ELIQUIS 5MG TABLET / ORAL AB RLD, RS 2012-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202155-001 ELIQUIS 2.5MG TABLET / ORAL AB RLD 2012-12-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202155-002 ELIQUIS 5MG TABLET / ORAL AB RLD, RS 2012-12-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202155-001 ELIQUIS 2.5MG TABLET / ORAL AB RLD 2012-12-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202155-002 ELIQUIS 5MG TABLET / ORAL AB RLD, RS 2012-12-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202155-001 ELIQUIS 2.5MG TABLET / ORAL AB RLD 2012-12-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202155-002 ELIQUIS 5MG TABLET / ORAL AB RLD, RS 2012-12-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202155-001 ELIQUIS 2.5MG TABLET / ORAL AB RLD 2012-12-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202155-002 ELIQUIS 5MG TABLET / ORAL AB RLD, RS 2012-12-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202155-001 ELIQUIS 2.5MG TABLET / ORAL AB RLD 2012-12-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N202155-002 ELIQUIS 5MG TABLET / ORAL AB RLD, RS 2012-12-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202155-001 ELIQUIS 2.5MG TABLET / ORAL AB RLD 2012-12-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202155-002 ELIQUIS 5MG TABLET / ORAL AB RLD, RS 2012-12-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202155-001 ELIQUIS 2.5MG TABLET / ORAL AB RLD 2012-12-28 5d02ea3f76ae…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
Observed Orange Book patent history# Patent history page 1 of 19 · 733 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N202155-001 6967208 2026-11-21 U-1501 Drug substance, Drug product 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-001 6967208 2026-11-21 U-1200 Drug substance, Drug product 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-001 6967208 2026-11-21 U-1302 Drug substance, Drug product 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-001 6967208 2026-11-21 U-1729 Drug substance, Drug product 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-001 6967208 2026-11-21 U-1730 Drug substance, Drug product 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-001 6967208 2026-11-21 U-1301 Drug substance, Drug product 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-001 6967208 2026-11-21 U-1167 Drug substance, Drug product 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-001 6967208 2026-11-21 U-4178 Drug substance, Drug product 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-001 6967208 2026-11-21 U-1323 Drug substance, Drug product 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-001 6967208 2026-11-21 U-1502 Drug substance, Drug product 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-001 6967208*PED 2027-05-21 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-001 9326945 2031-02-24 Drug product 2016-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-001 9326945*PED 2031-08-24 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-002 6967208 2026-11-21 U-1301 Drug substance, Drug product 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-002 6967208 2026-11-21 U-1200 Drug substance, Drug product 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-002 6967208 2026-11-21 U-1302 Drug substance, Drug product 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-002 6967208 2026-11-21 U-1323 Drug substance, Drug product 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-002 6967208 2026-11-21 U-4178 Drug substance, Drug product 2013-01-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-002 6967208*PED 2027-05-21 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-002 9326945 2031-02-24 Drug product 2016-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-002 9326945*PED 2031-08-24 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-003 6967208 2026-11-21 U-4179 Drug substance, Drug product 2025-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-003 6967208*PED 2027-05-21 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-003 9326945 2031-02-24 Drug product 2025-05-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202155-003 9326945*PED 2031-08-24 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N202155-001 6967208 2026-11-21 U-1501 Drug substance, Drug product 2013-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202155-001 6967208 2026-11-21 U-1200 Drug substance, Drug product 2013-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202155-001 6967208 2026-11-21 U-1302 Drug substance, Drug product 2013-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202155-001 6967208 2026-11-21 U-1729 Drug substance, Drug product 2013-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202155-001 6967208 2026-11-21 U-1730 Drug substance, Drug product 2013-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202155-001 6967208 2026-11-21 U-1301 Drug substance, Drug product 2013-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202155-001 6967208 2026-11-21 U-1167 Drug substance, Drug product 2013-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202155-001 6967208 2026-11-21 U-4178 Drug substance, Drug product 2013-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202155-001 6967208 2026-11-21 U-1323 Drug substance, Drug product 2013-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202155-001 6967208 2026-11-21 U-1502 Drug substance, Drug product 2013-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202155-001 6967208*PED 2027-05-21 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202155-001 9326945 2031-02-24 Drug product 2016-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202155-001 9326945*PED 2031-08-24 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202155-002 6967208 2026-11-21 U-1301 Drug substance, Drug product 2013-01-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202155-002 6967208 2026-11-21 U-1200 Drug substance, Drug product 2013-01-25 caaa826d4ba7…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.