ELIQUIS

Product NDC: 63629-7747
Requested package NDC: 63629-7747-1
11-digit product format: 636297747
Labeler code: 63629
Product ID: 63629-7747_dbf07ee1-d09a-4d12-9812-58a76e96ef10
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: apixaban
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA202155
Marketing category: NDA
Marketing start: 2012-12-28
Marketing end: 0000-00-00
Substance: APIXABAN
Active strength: 5 mg/1
Pharmacologic classes: Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63629-7747	63629-7747-1	D	Discontinued by firm		2026-10-05

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.

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 · 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N202155-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202155-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202155-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202155-002	AB	1	`caaa826d4ba7…`
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…`

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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N202155-001	NPP	2028-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202155-001	PED	2028-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202155-002	NPP	2028-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202155-002	PED	2028-10-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202155-003	NS	2028-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202155-003	PED	2028-10-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202155-001	NPP	2028-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202155-001	PED	2028-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202155-002	NPP	2028-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202155-002	PED	2028-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202155-003	NS	2028-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202155-003	PED	2028-10-17	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-7747	ELIQUIS (APIXABAN) TABLET, FILM COATED [BRYANT RANCH PREPACK]	5	Legacy NDC	20231115_dbf07ee1-d09a-4d12-9812-58a76e96ef10.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
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-7747-1	63629774701	60 TABLET, FILM COATED in 1 BOTTLE (63629-7747-1)	2018-06-13	0000-00-00	No	No	Current