PRADAXA

Product NDC: 21695-899
11-digit product format: 216950899
Labeler code: 21695
Product ID: 21695-899_5db7f199-8752-4d24-85f7-e34ca8f4d02e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dabigatran etexilate mesylate
Dosage form: CAPSULE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA022512
Marketing category: NDA
Marketing start: 2010-10-26
Marketing end: 0000-00-00
Substance: DABIGATRAN ETEXILATE MESYLATE
Active strength: 150 mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-899		I	Inactivated by FDA		2026-08-17
excluded package	package	21695-899	21695-899-60	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-899-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-899-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-899-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-899-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-899-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-899-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-899-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-899-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-899-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-899-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-899-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-899-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-899-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-899-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-899-60	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-899-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-899-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-899-60	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-899-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-899-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-899-60	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-899-60	`110d247fa046…`	`a55b01930146…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
eb3de627-dc34-4a6a-871e-eb129f31c153	Product name	5	20260303
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
38a612c3-e18f-450b-8874-6e78282bc5f1	Product name	1	20220118
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-899-60	2019-09-24	C162847	48780-1	934fe258-4869-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use PRADAXA safely and effectively. See full prescribing information for PRADAXA. PRADAXA® (dabigatran etexilate mesylate) capsules for oral use Initial U.S. Approval: 2010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-899-60	PRADAXA	60 in 1 BOTTLE	CAPSULE	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-899-60	EA - Each	21695-899	dcd6f5f8-e136-445d-9e0b-2531c581f967	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
dabigatran etexilate mesylate	ACTIVE INGREDIENT	SC7NUW5IIT	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
dabigatran etexilate	ACTIVE MOIETY	2E18WX195X	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
CARRAGEENAN	INACTIVE INGREDIENT	5C69YCD2YJ	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
METHYL ALCOHOL	INACTIVE INGREDIENT	Y4S76JWI15	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
POTASSIUM CHLORIDE	INACTIVE INGREDIENT	660YQ98I10	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-899	PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110414_5db7f199-8752-4d24-85f7-e34ca8f4d02e.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 · 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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SC7NUW5IIT	DABIGATRAN ETEXILATE MESYLATE	872728-81-9	DABIGATRAN ETEXILATE MESYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1037045	dabigatran etexilate 150 MG Oral Capsule	PSN	5db7f199-8752-4d24-85f7-e34ca8f4d02e	1
1037049	Pradaxa 150 MG Oral Capsule	PSN	5db7f199-8752-4d24-85f7-e34ca8f4d02e	1
1037049	dabigatran etexilate 150 MG Oral Capsule [Pradaxa]	SBD	5db7f199-8752-4d24-85f7-e34ca8f4d02e	1
1037045	dabigatran etexilate 150 MG Oral Capsule	SCD	5db7f199-8752-4d24-85f7-e34ca8f4d02e	1
1037045	dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral Capsule	SY	5db7f199-8752-4d24-85f7-e34ca8f4d02e	1
1037049	Pradaxa 150 MG (as dabigatran etexilate mesylate 172.95 MG) Oral Capsule	SY	5db7f199-8752-4d24-85f7-e34ca8f4d02e	1
1037049	Pradaxa 150 MG Oral Capsule	SY	5db7f199-8752-4d24-85f7-e34ca8f4d02e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-899-60	21695089960	60 in 1 BOTTLE	Historical