Home NDC 71610-811 ELIQUIS
Product NDC 71610-811
11-digit product format 716100811
Labeler code 71610
Product ID 71610-811_2d3e63c1-62ea-0c12-e063-6394a90aa931
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name apixaban
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application NDA202155
Marketing category NDA
Marketing start 2012-12-28
Substance APIXABAN
Active strength 2.5 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 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.
Additional Listing Data#
Finished product Yes
Brand name base ELIQUIS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength APIXABAN 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3Z9Y7UWC1J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1364435 Internal RxNorm lookup 1364441 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71610-811-42 ELIQUIS 1800 in 1 BOTTLE TABLET, FILM COATED 1800 2 71610-811-80 ELIQUIS 180 in 1 BOTTLE TABLET, FILM COATED 180 2 71610-811-83 ELIQUIS 3600 in 1 BOTTLE TABLET, FILM COATED 3600 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-811 ELIQUIS (APIXABAN) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] 2 Current NDC, 3 package rows 20250205_1523ab32-2c2c-6501-e063-6394a90aa0b3.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 · 6 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ELIQUIS APIXABAN Cardinal Health 107, LLC a454cd24-0c6d-46e8-b1e4-197388606175 2026-04-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 202155 application number: NDA202155 ELIQUIS APIXABAN Aphena Pharma Solutions - Tennessee, LLC 1523ab32-2c2c-6501-e063-6394a90aa0b3 2025-02-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 202155 application number: NDA202155 ndc (product): 71610-811 ELIQUIS APIXABAN A-S Medication Solutions 33a9046a-41cc-46c1-becc-2ff4d7d71538 2024-11-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 202155 application number: NDA202155 ELIQUIS APIXABAN Proficient Rx LP 33752f5d-2ca7-45c0-8292-b54742219b97 2024-06-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 202155 application number: NDA202155 ELIQUIS APIXABAN A-S Medication Solutions 2f47aa0e-0235-4220-85dd-dfcb8ad0d009 2023-05-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 202155 application number: NDA202155 ELIQUIS APIXABAN A-S Medication Solutions fd383ae7-1e34-44ef-b8f1-ca6906dfbcef 2023-05-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 202155 application number: NDA202155
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71610-811-42 71610081142 1800 TABLET, FILM COATED in 1 BOTTLE (71610-811-42) 2025-01-27 No No Current 71610-811-80 71610081180 180 TABLET, FILM COATED in 1 BOTTLE (71610-811-80) 2025-01-27 No No Current 71610-811-83 71610081183 3600 TABLET, FILM COATED in 1 BOTTLE (71610-811-83) 2024-03-28 No No Current