Application 022512

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	EQ 75MG BASE	Yes	No
002	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	EQ 150MG BASE	Yes	Yes
003	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	EQ 110MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N022512-001	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2010-10-19
N022512-002	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-10-19
N022512-003	PRADAXA	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	RLD	2015-11-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N022512-001	AB
N022512-002	AB
N022512-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022512-001	7932273	2025-09-07		Drug substance, Drug product	2011-08-01
N022512-001	7932273*PED	2026-03-07		Pediatric extension
N022512-001	9034822	2031-01-20	U-1759		2015-11-09
N022512-001	9034822*PED	2031-07-20		Pediatric extension
N022512-002	7932273	2025-09-07		Drug substance, Drug product
N022512-002	7932273*PED	2026-03-07		Pediatric extension
N022512-002	9034822	2031-01-20	U-1759		2015-11-09
N022512-002	9034822*PED	2031-07-20		Pediatric extension
N022512-003	7932273	2025-09-07		Drug substance, Drug product	2015-12-15
N022512-003	7932273*PED	2026-03-07		Pediatric extension
N022512-003	9034822	2031-01-20	U-1759		2015-12-15
N022512-003	9034822*PED	2031-07-20		Pediatric extension

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 4 · 126 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
2026-08-18 06:07:40	2026-07	N022512-001	PRADAXA	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2010-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022512-002	PRADAXA	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022512-003	PRADAXA	EQ 110MG BASE	CAPSULE / ORAL	AB	RLD	2015-11-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022512-001	PRADAXA	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2010-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022512-002	PRADAXA	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022512-003	PRADAXA	EQ 110MG BASE	CAPSULE / ORAL	AB	RLD	2015-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022512-001	PRADAXA	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2010-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022512-002	PRADAXA	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022512-003	PRADAXA	EQ 110MG BASE	CAPSULE / ORAL	AB	RLD	2015-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022512-001	PRADAXA	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2010-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022512-002	PRADAXA	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022512-003	PRADAXA	EQ 110MG BASE	CAPSULE / ORAL	AB	RLD	2015-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022512-001	PRADAXA	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2010-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022512-002	PRADAXA	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022512-003	PRADAXA	EQ 110MG BASE	CAPSULE / ORAL	AB	RLD	2015-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022512-001	PRADAXA	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2010-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022512-002	PRADAXA	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022512-003	PRADAXA	EQ 110MG BASE	CAPSULE / ORAL	AB	RLD	2015-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022512-001	PRADAXA	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2010-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022512-002	PRADAXA	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022512-003	PRADAXA	EQ 110MG BASE	CAPSULE / ORAL	AB	RLD	2015-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022512-001	PRADAXA	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2010-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022512-002	PRADAXA	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022512-003	PRADAXA	EQ 110MG BASE	CAPSULE / ORAL	AB	RLD	2015-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022512-001	PRADAXA	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2010-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022512-002	PRADAXA	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022512-003	PRADAXA	EQ 110MG BASE	CAPSULE / ORAL	AB	RLD	2015-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022512-001	PRADAXA	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2010-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022512-002	PRADAXA	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022512-003	PRADAXA	EQ 110MG BASE	CAPSULE / ORAL	AB	RLD	2015-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022512-001	PRADAXA	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2010-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022512-002	PRADAXA	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022512-003	PRADAXA	EQ 110MG BASE	CAPSULE / ORAL	AB	RLD	2015-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022512-001	PRADAXA	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2010-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022512-002	PRADAXA	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022512-003	PRADAXA	EQ 110MG BASE	CAPSULE / ORAL	AB	RLD	2015-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022512-001	PRADAXA	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2010-10-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022512-002	PRADAXA	EQ 150MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-10-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022512-003	PRADAXA	EQ 110MG BASE	CAPSULE / ORAL	AB	RLD	2015-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022512-001	PRADAXA	EQ 75MG BASE	CAPSULE / ORAL	AB	RLD	2010-10-19	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 94 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022512-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022512-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022512-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022512-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022512-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022512-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022512-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022512-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022512-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022512-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022512-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022512-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022512-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022512-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022512-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022512-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022512-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022512-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022512-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022512-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022512-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022512-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022512-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022512-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022512-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022512-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022512-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022512-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022512-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022512-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022512-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022512-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022512-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022512-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022512-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022512-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022512-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022512-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022512-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022512-001	AB	1	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 782 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022512-001	7932273	2025-09-07		Drug substance, Drug product	2011-08-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022512-001	7932273*PED	2026-03-07		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022512-001	9034822	2031-01-20	U-1759		2015-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022512-001	9034822*PED	2031-07-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022512-002	7932273	2025-09-07		Drug substance, Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022512-002	7932273*PED	2026-03-07		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022512-002	9034822	2031-01-20	U-1759		2015-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022512-002	9034822*PED	2031-07-20		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022512-003	7932273	2025-09-07		Drug substance, Drug product	2015-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022512-003	7932273*PED	2026-03-07		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022512-003	9034822	2031-01-20	U-1759		2015-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022512-003	9034822*PED	2031-07-20		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022512-001	7932273	2025-09-07		Drug substance, Drug product	2011-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022512-001	7932273*PED	2026-03-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022512-001	9034822	2031-01-20	U-1759		2015-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022512-001	9034822*PED	2031-07-20		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022512-002	7932273	2025-09-07		Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022512-002	7932273*PED	2026-03-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022512-002	9034822	2031-01-20	U-1759		2015-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022512-002	9034822*PED	2031-07-20		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022512-003	7932273	2025-09-07		Drug substance, Drug product	2015-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022512-003	7932273*PED	2026-03-07		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022512-003	9034822	2031-01-20	U-1759		2015-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022512-003	9034822*PED	2031-07-20		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022512-001	7932273	2025-09-07		Drug substance, Drug product	2011-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022512-001	7932273*PED	2026-03-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022512-001	9034822	2031-01-20	U-1759		2015-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022512-001	9034822*PED	2031-07-20		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022512-002	7932273	2025-09-07		Drug substance, Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022512-002	7932273*PED	2026-03-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022512-002	9034822	2031-01-20	U-1759		2015-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022512-002	9034822*PED	2031-07-20		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022512-003	7932273	2025-09-07		Drug substance, Drug product	2015-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022512-003	7932273*PED	2026-03-07		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022512-003	9034822	2031-01-20	U-1759		2015-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022512-003	9034822*PED	2031-07-20		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022512-001	7932273	2025-09-07		Drug substance, Drug product	2011-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022512-001	7932273*PED	2026-03-07		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022512-001	9034822	2031-01-20	U-1759		2015-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022512-001	9034822*PED	2031-07-20		Pediatric extension		`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 162 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022512-001	I-862	2024-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022512-001	PED	2024-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022512-002	I-862	2024-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022512-002	PED	2024-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022512-003	I-862	2024-06-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022512-003	PED	2024-12-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022512-001	I-862	2024-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022512-001	PED	2024-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022512-002	I-862	2024-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022512-002	PED	2024-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022512-003	I-862	2024-06-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022512-003	PED	2024-12-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022512-001	I-862	2024-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022512-001	PED	2024-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022512-002	I-862	2024-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022512-002	PED	2024-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022512-003	I-862	2024-06-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022512-003	PED	2024-12-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022512-001	I-862	2024-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022512-001	PED	2024-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022512-002	I-862	2024-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022512-002	PED	2024-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022512-003	I-862	2024-06-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022512-003	PED	2024-12-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022512-001	I-862	2024-06-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022512-001	PED	2024-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022512-002	I-862	2024-06-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022512-002	PED	2024-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022512-003	I-862	2024-06-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022512-003	PED	2024-12-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022512-001	I-862	2024-06-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022512-001	PED	2024-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022512-002	I-862	2024-06-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022512-002	PED	2024-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022512-003	I-862	2024-06-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022512-003	PED	2024-12-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022512-001	I-862	2024-06-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022512-001	PED	2024-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022512-002	I-862	2024-06-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022512-002	PED	2024-12-21	`301d65b070ca…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pradaxa	DABIGATRAN ETEXILATE MESYLATE	Boehringer Ingelheim Pharmaceuticals Inc.	ba74e3cd-b06f-4145-b284-5fd6b84ff3c9	2025-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022512 application number: NDA022512 ndc (product): 0597-0360 ndc (product): 0597-0355 ndc (product): 0597-0108

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0108	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0108	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0108	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0108	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0108	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0108	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0108	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0135	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0135	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0149	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0355	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0355	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0355	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0355	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0355	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0355	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0355	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0360	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0360	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0360	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0360	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0360	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0360	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
0597-0360	Pradaxa	dabigatran etexilate mesylate	Boehringer Ingelheim Pharmaceuticals Inc.	NDA	Current
21695-899	PRADAXA	dabigatran etexilate mesylate	Rebel Distributors Corp	NDA	Current
50090-3617	Pradaxa	dabigatran etexilate mesylate	A-S Medication Solutions	NDA	Current
50090-3617	Pradaxa	dabigatran etexilate mesylate	A-S Medication Solutions	NDA	Current
50090-3617	Pradaxa	dabigatran etexilate mesylate	A-S Medication Solutions	NDA	Current
50090-3617	Pradaxa	dabigatran etexilate mesylate	A-S Medication Solutions	NDA	Current
50090-4480	Pradaxa	dabigatran etexilate mesylate	A-S Medication Solutions	NDA	Current
50090-4480	Pradaxa	dabigatran etexilate mesylate	A-S Medication Solutions	NDA	Current
50090-4480	Pradaxa	dabigatran etexilate mesylate	A-S Medication Solutions	NDA	Current
50090-4480	Pradaxa	dabigatran etexilate mesylate	A-S Medication Solutions	NDA	Current
50090-4480	Pradaxa	dabigatran etexilate mesylate	A-S Medication Solutions	NDA	Current
63629-8242	Pradaxa	dabigatran etexilate mesylate	Bryant Ranch Prepack	NDA	Current
63629-8242	Pradaxa	dabigatran etexilate mesylate	Bryant Ranch Prepack	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83206	SUPPL	2025-10-03
82606	SUPPL	2025-10-03
83097	SUPPL	2025-08-13
82607	SUPPL	2025-06-20
76640	SUPPL	2024-01-12
76636	SUPPL	2023-11-20
67870	SUPPL	2021-06-23
67849	SUPPL	2021-06-22
67848	SUPPL	2021-06-22
67154	SUPPL	2021-04-22
67133	SUPPL	2021-04-22
63791	SUPPL	2020-07-06
63782	SUPPL	2020-07-02
63781	SUPPL	2020-07-02
61052	SUPPL	2019-11-26
61044	SUPPL	2019-11-25
61043	SUPPL	2019-11-25
52983	SUPPL	2018-03-15
52977	SUPPL	2018-03-15
38798	SUPPL	2015-11-25
7486	SUPPL	2015-11-23
38799	SUPPL	2015-10-27
7487	SUPPL	2015-10-26
17667	SUPPL	2015-09-21
7485	SUPPL	2015-09-14
38797	SUPPL	2015-09-11
29813	SUPPL	2015-08-28
38795	SUPPL	2015-01-20
7483	SUPPL	2015-01-20
38796	SUPPL	2014-09-26
7484	SUPPL	2014-09-08
38794	SUPPL	2014-08-15
7482	SUPPL	2014-08-15
29812	SUPPL	2014-04-09
38792	SUPPL	2014-04-08
7481	SUPPL	2013-12-13
38793	SUPPL	2013-12-11
22043	SUPPL	2013-06-04
29811	SUPPL	2013-04-30
38791	SUPPL	2013-04-29
42544	SUPPL	2013-04-10
23407	ORIG	2013-01-03
29810	SUPPL	2012-12-26
38790	SUPPL	2012-12-21
38789	SUPPL	2012-11-06
7480	SUPPL	2012-11-06
17666	SUPPL	2012-06-11
29809	SUPPL	2012-06-05
29808	SUPPL	2012-05-02
17665	SUPPL	2012-05-01
38788	SUPPL	2012-01-23
29807	SUPPL	2012-01-19
7479	SUPPL	2011-11-14
38787	SUPPL	2011-11-10
7478	SUPPL	2011-04-07
44186	ORIG	2011-03-29
29806	SUPPL	2011-03-08
38786	SUPPL	2011-03-07
24328	ORIG	2011-02-17
22042	ORIG	2010-11-30
29805	ORIG	2010-10-20
17664	ORIG	2010-10-20