DABIGATRAN

Product NDC: 50268-200
11-digit product format: 502680200
Labeler code: 50268
Product ID: 50268-200_43cbae6c-3c71-51aa-e063-6394a90a6d9a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DABIGATRAN ETEXILATE
Dosage form: CAPSULE
Route: ORAL
Labeler: AvPAK
Application: ANDA213879
Marketing category: ANDA
Marketing start: 2025-07-12
Substance: DABIGATRAN ETEXILATE MESYLATE
Active strength: 150 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 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	Approval date
A213879-001	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2024-05-22
A213879-002	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-05-22
A213879-003	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213879-001	AB
A213879-002	AB
A213879-003	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 2 · 42 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
2026-08-18 06:07:40	2026-07	A213879-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2024-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213879-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213879-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213879-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2024-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213879-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213879-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213879-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2024-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213879-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213879-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213879-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2024-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213879-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213879-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213879-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2024-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213879-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213879-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213879-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2024-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213879-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213879-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213879-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2024-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213879-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213879-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213879-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2024-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213879-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213879-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213879-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2024-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213879-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213879-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213879-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2024-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213879-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213879-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213879-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2024-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213879-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213879-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213879-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2024-05-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213879-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213879-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2024-05-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213879-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213879-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2024-05-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213879-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2024-05-22	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213879-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2024-05-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A213879-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213879-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213879-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213879-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213879-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213879-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213879-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213879-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213879-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213879-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213879-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213879-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213879-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213879-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213879-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213879-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213879-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213879-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213879-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213879-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213879-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213879-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213879-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213879-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213879-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213879-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213879-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213879-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213879-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213879-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213879-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213879-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213879-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213879-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213879-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213879-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213879-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213879-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213879-002	AB	1	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213879-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DABIGATRAN ETEXILATE MESYLATE	150 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1037045	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
39ac558a-b375-f3c1-e063-6394a90aa901	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	Strength	SPL version
50268-200-11	DABIGATRAN	1 in 1 BLISTER PACK	CAPSULE	1		2
50268-200-16	DABIGATRAN	60 in 1 BOX	CAPSULE	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-200-11	EA - Each	50268-200	79213190-1882-4842-b4f6-e3bc08ec96bf	1	2025-08-11
50268-200-16	EA - Each	50268-200	d1e377be-c06a-4806-a77c-1a4a2985317d	1	2025-08-11

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
DABIGATRAN	DABIGATRAN ETEXILATE	American Health Packaging	f7ea7e2c-ca54-4ecc-9fc7-bd3571b0ebc2	2026-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213879 application number: ANDA213879
DABIGATRAN	DABIGATRAN ETEXILATE	Novadoz Pharmaceuticals LLC	6f79088b-b353-485a-9df4-6f5088f5bd0f	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213879 application number: ANDA213879
DABIGATRAN	DABIGATRAN ETEXILATE	AvKARE	27e95caf-7938-ef8e-e063-6394a90a6a1a	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213879 application number: ANDA213879
DABIGATRAN	DABIGATRAN ETEXILATE	AvPAK	39ac558a-b375-f3c1-e063-6394a90aa901	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213879 application number: ANDA213879 ndc (product): 50268-200
DABIGATRAN	DABIGATRAN ETEXILATE	A-S Medication Solutions	bee57f1b-ee5f-4f81-ae6f-ea65ddf9a174	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213879 application number: ANDA213879
DABIGATRAN	DABIGATRAN ETEXILATE	A-S Medication Solutions	e4e3b992-621a-43a5-be59-eeb5083fd2b4	2025-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213879 application number: ANDA213879

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
1037045	dabigatran etexilate 150 MG Oral Capsule	PSN	39ac558a-b375-f3c1-e063-6394a90aa901	2
1037045	dabigatran etexilate 150 MG Oral Capsule	SCD	39ac558a-b375-f3c1-e063-6394a90aa901	2
1037045	dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral Capsule	SY	39ac558a-b375-f3c1-e063-6394a90aa901	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50268-200-11	50268020011	1 in 1 BLISTER PACK					Historical
50268-200-16	50268020016	60 BLISTER PACK in 1 BOX (50268-200-16) / 1 CAPSULE in 1 BLISTER PACK (50268-200-11)	60 blister pack	2025-07-12	No	No	Current