Dabigatran Etexilate

Product NDC: 31722-666
11-digit product format: 317220666
Labeler code: 31722
Product ID: 31722-666_3b236998-0037-d34f-e063-6294a90a03f5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dabigatran Etexilate
Dosage form: CAPSULE
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA207961
Marketing category: ANDA
Marketing start: 2024-08-13
Substance: DABIGATRAN ETEXILATE MESYLATE
Active strength: 110 mg/1
Pharmacologic classes: Direct Thrombin Inhibitor [EPC], Thrombin 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	Approval date
A207961-001	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06
A207961-002	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06
A207961-003	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207961-001	AB
A207961-002	AB
A207961-003	AB

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 · 85 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207961-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207961-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-05-06	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207961-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-05-06	`5c6f7cd8ea54…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 85 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	A207961-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207961-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207961-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207961-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207961-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207961-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207961-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207961-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207961-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207961-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207961-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207961-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207961-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207961-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207961-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207961-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207961-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207961-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207961-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207961-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207961-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207961-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207961-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207961-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207961-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207961-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207961-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207961-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207961-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207961-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207961-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207961-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207961-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207961-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207961-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207961-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207961-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207961-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207961-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207961-002	AB	1	`5c6f7cd8ea54…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dabigatran Etexilate	DABIGATRAN ETEXILATE	NorthStar RxLLC	d5937f27-88c7-4c4a-801e-4c8945008982	2025-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207961 application number: ANDA207961
Dabigatran Etexilate	DABIGATRAN ETEXILATE	Camber Pharmaceuticals, Inc.	3c24e235-218b-438e-9456-42c18ff01913	2025-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207961 application number: ANDA207961 ndc (product): 31722-666
Dabigatran Etexilate	DABIGATRAN ETEXILATE	XLCare Pharmaceuticals, Inc.	19b3bfc1-4fcb-4eb9-a611-02c27c05c56e	2023-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207961 application number: ANDA207961

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DABIGATRAN ETEXILATE MESYLATE	110 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SC7NUW5IIT	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1037045	Internal RxNorm lookup
1037179	Internal RxNorm lookup
1723476	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
3c24e235-218b-438e-9456-42c18ff01913	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
eb3de627-dc34-4a6a-871e-eb129f31c153	Product name	5	20260303
38a612c3-e18f-450b-8874-6e78282bc5f1	Product name	1	20220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
31722-666-32	Dabigatran Etexilate	10 in 1 CARTON	CAPSULE	10	8
31722-666-32	Dabigatran Etexilate	6 in 1 BLISTER PACK	CAPSULE	6	8
31722-666-60	Dabigatran Etexilate	60 in 1 BOTTLE	CAPSULE	60	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-666-32	EA - Each	31722-666	38d2998c-6e49-4b3a-91ed-4968a46fd13a	1	2024-10-04
31722-666-60	EA - Each	31722-666	1fc7cba1-2b1f-480f-b7a1-e0a660f12840	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-666	DABIGATRAN ETEXILATE (DABIGATRAN ETEXILATE) CAPSULE [CAMBER PHARMACEUTICALS, INC.]	7	Current NDC, 3 package rows	20250213_3c24e235-218b-438e-9456-42c18ff01913.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SC7NUW5IIT	DABIGATRAN ETEXILATE MESYLATE	872728-81-9	DABIGATRAN ETEXILATE MESYLATE
2E18WX195X	DABIGATRAN ETEXILATE	211915-06-9	Dabigatran Etexilate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1723476	dabigatran etexilate 110 MG Oral Capsule	PSN	3c24e235-218b-438e-9456-42c18ff01913	8
1037045	dabigatran etexilate 150 MG Oral Capsule	PSN	3c24e235-218b-438e-9456-42c18ff01913	8
1037179	dabigatran etexilate 75 MG Oral Capsule	PSN	3c24e235-218b-438e-9456-42c18ff01913	8
1723476	dabigatran etexilate 110 MG Oral Capsule	SCD	3c24e235-218b-438e-9456-42c18ff01913	8
1037045	dabigatran etexilate 150 MG Oral Capsule	SCD	3c24e235-218b-438e-9456-42c18ff01913	8
1037179	dabigatran etexilate 75 MG Oral Capsule	SCD	3c24e235-218b-438e-9456-42c18ff01913	8
1723476	dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral Capsule	SY	3c24e235-218b-438e-9456-42c18ff01913	8
1037045	dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral Capsule	SY	3c24e235-218b-438e-9456-42c18ff01913	8
1037179	dabigatran etexilate 75 MG (as dabigatran etexilate mesylate 86.48 MG) Oral Capsule	SY	3c24e235-218b-438e-9456-42c18ff01913	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
31722-666-32	31722066632	10 BLISTER PACK in 1 CARTON (31722-666-32) / 6 CAPSULE in 1 BLISTER PACK	10 blister pack	2024-08-13	No	No	Current
31722-666-60	31722066660	60 CAPSULE in 1 BOTTLE (31722-666-60)	60 capsule	2024-08-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dabigatran Etexilate	Camber Pharmaceuticals, Inc. \| Hetero Labs Limited Unit III	2025-07-30	HUMAN PRESCRIPTION DRUG LABEL	8