ELIQUIS

Product NDC: 82804-085
11-digit product format: 828040085
Labeler code: 82804
Product ID: 82804-085_1d796c29-7ed2-407f-abdd-7d2cc4c80e83
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: apixaban
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: NDA202155
Marketing category: NDA
Marketing start: 2012-12-28
Substance: APIXABAN
Active strength: 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 1.

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.

Application-product, TE code table
Application-product	TE code
N202155-001	AB
N202155-002	AB

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.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N202155-001	NPP	2028-04-17
N202155-001	PED	2028-10-17
N202155-002	NPP	2028-04-17
N202155-002	PED	2028-10-17
N202155-003	NS	2028-04-17
N202155-003	PED	2028-10-17

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 · 86 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
2026-02-19 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…`
2022-04-08 23:34 UTC	2022-04	N202155-002	ELIQUIS	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202155-002	ELIQUIS	5MG	TABLET / ORAL	AB	RLD, RS	2012-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL		RLD	2012-12-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202155-002	ELIQUIS	5MG	TABLET / ORAL		RLD, RS	2012-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202155-001	ELIQUIS	2.5MG	TABLET / ORAL	AB	RLD	2012-12-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202155-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202155-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202155-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202155-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202155-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202155-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202155-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202155-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202155-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202155-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202155-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202155-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202155-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202155-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202155-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202155-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202155-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202155-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202155-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202155-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202155-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202155-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202155-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202155-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202155-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202155-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202155-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202155-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202155-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202155-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202155-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N202155-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202155-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202155-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N202155-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202155-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202155-002	AB	1	`87673890dc5c…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 683 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-1501	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-1200	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-1302	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-1729	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-1730	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-1301	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-1167	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-4178	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-1323	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208	2026-11-21	U-1502	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	6967208*PED	2027-05-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	9326945	2031-02-24		Drug product	2016-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	9326945*PED	2031-08-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	6967208	2026-11-21	U-1301	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	6967208	2026-11-21	U-1200	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	6967208	2026-11-21	U-1302	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	6967208	2026-11-21	U-1323	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	6967208	2026-11-21	U-4178	Drug substance, Drug product	2013-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	6967208*PED	2027-05-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	9326945	2031-02-24		Drug product	2016-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	9326945*PED	2031-08-24		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-003	6967208	2026-11-21	U-4179	Drug substance, Drug product	2025-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-003	6967208*PED	2027-05-21		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-003	9326945	2031-02-24		Drug product	2025-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-003	9326945*PED	2031-08-24		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-1501	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-1200	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-1302	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-1729	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-1730	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-1301	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-1167	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-4178	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-1323	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208	2026-11-21	U-1502	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	6967208*PED	2027-05-21		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	9326945	2031-02-24		Drug product	2016-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	9326945*PED	2031-08-24		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-002	6967208	2026-11-21	U-1301	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-002	6967208	2026-11-21	U-1200	Drug substance, Drug product	2013-01-25	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202155-001	NPP	2028-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-001	PED	2028-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	NPP	2028-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-002	PED	2028-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-003	NS	2028-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202155-003	PED	2028-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	NPP	2028-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-001	PED	2028-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-002	NPP	2028-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-002	PED	2028-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-003	NS	2028-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202155-003	PED	2028-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202155-001	NPP	2028-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202155-001	PED	2028-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202155-002	NPP	2028-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202155-002	PED	2028-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202155-003	NS	2028-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202155-003	PED	2028-10-17	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202155-001	NPP	2028-04-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202155-001	PED	2028-10-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202155-002	NPP	2028-04-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202155-002	PED	2028-10-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202155-003	NS	2028-04-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N202155-003	PED	2028-10-17	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
APIXABAN	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
1364445	Internal RxNorm lookup
1364447	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
33752f5d-2ca7-45c0-8292-b54742219b97	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
89fbc7dd-7e16-8a82-0070-9b9487bb8075	Product name	5	20260129

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
82804-085-30	ELIQUIS	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	2
82804-085-31	ELIQUIS	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	2
82804-085-31	ELIQUIS	3 in 1 BAG	TABLET, FILM COATED	3	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-085-30	EA - Each	82804-085	f863bd04-aae8-41eb-94c3-5a8a41be020a	1	2024-08-12
82804-085-31	EA - Each	82804-085	dde7fa30-9d99-4334-8886-e383489f7149	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82804-085	ELIQUIS (APIXABAN) TABLET, FILM COATED [PROFICIENT RX LP]	2	Current NDC, 3 package rows	20240629_33752f5d-2ca7-45c0-8292-b54742219b97.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 · 8 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	REMEDYREPACK INC.	7be1f4c1-bb2f-4ded-ae9a-515d2a22f93e	2025-08-29	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
ELIQUIS	APIXABAN	Aphena Pharma Solutions - Tennessee, LLC	41a133ef-e461-48ad-8221-b735bdd0ec25	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202155 application number: NDA202155
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 ndc (product): 82804-085
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3Z9Y7UWC1J	APIXABAN	503612-47-3	APIXABAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1364445	apixaban 5 MG Oral Tablet	PSN	33752f5d-2ca7-45c0-8292-b54742219b97	2
1364447	Eliquis 5 MG Oral Tablet	PSN	33752f5d-2ca7-45c0-8292-b54742219b97	2
1364447	apixaban 5 MG Oral Tablet [Eliquis]	SBD	33752f5d-2ca7-45c0-8292-b54742219b97	2
1364445	apixaban 5 MG Oral Tablet	SCD	33752f5d-2ca7-45c0-8292-b54742219b97	2
1364447	Eliquis 5 MG Oral Tablet	SY	33752f5d-2ca7-45c0-8292-b54742219b97	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82804-085-30	82804008530	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82804-085-30)		2024-05-30	No	No	Current
82804-085-31	82804008531	3 BLISTER PACK in 1 BAG (82804-085-31) / 10 TABLET, FILM COATED in 1 BLISTER PACK	3 blister pack	2024-06-27	No	No	Current