Dabigatran Etexilate

Product NDC: 0904-7253
11-digit product format: 009047253
Labeler code: 0904
Product ID: 0904-7253_869fd2f3-9357-4148-8b64-0cca96dd5f75
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Dabigatran Etexilate
Dosage form: CAPSULE, COATED PELLETS
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA208040
Marketing category: ANDA
Marketing start: 2025-06-23
Substance: DABIGATRAN ETEXILATE MESYLATE
Active strength: 75 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
A208040-001	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11
A208040-002	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11
A208040-003	DABIGATRAN ETEXILATE MESYLATE	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208040-001	AB
A208040-002	AB
A208040-003	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 · 88 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	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208040-003	DABIGATRAN ETEXILATE MESYLATE	EQ 110MG BASE	CAPSULE / ORAL	AB	2024-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208040-002	DABIGATRAN ETEXILATE MESYLATE	EQ 150MG BASE	CAPSULE / ORAL	AB	2020-03-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208040-001	DABIGATRAN ETEXILATE MESYLATE	EQ 75MG BASE	CAPSULE / ORAL	AB	2020-03-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 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	A208040-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208040-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208040-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208040-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208040-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208040-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208040-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208040-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208040-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208040-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208040-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208040-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208040-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208040-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208040-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208040-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208040-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208040-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208040-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208040-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208040-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208040-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208040-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208040-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208040-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208040-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208040-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208040-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208040-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208040-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208040-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208040-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208040-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208040-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208040-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208040-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208040-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208040-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208040-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208040-001	AB	1	`8072bd15b7f6…`

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	75 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
b76b79ce-b7dd-4390-b40e-71ae6c477d10	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
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
38a612c3-e18f-450b-8874-6e78282bc5f1	Product name	1	20220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0904-7253-04	Dabigatran Etexilate	3 in 1 CARTON	CAPSULE, COATED PELLETS	3	2
0904-7253-35	Dabigatran Etexilate	10 in 1 BLISTER PACK	CAPSULE, COATED PELLETS	10	2
0904-7253-68	Dabigatran Etexilate	6 in 1 CARTON	CAPSULE, COATED PELLETS	6	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7253-04	EA - Each	0904-7253	b5410e85-ccc2-4a3b-add3-7ae457359e35	1	2025-05-14
0904-7253-35	EA - Each	0904-7253	e9fe4203-0a1f-4844-9a60-5fe2c007f40d	1	2025-05-14
0904-7253-68	EA - Each	0904-7253	b8e42253-9fcb-4b5e-872e-6258a83d9eca	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7253	DABIGATRAN ETEXILATE CAPSULE, COATED PELLETS [MAJOR PHARMACEUTICALS]	1	Current NDC, 3 package rows	20250515_b76b79ce-b7dd-4390-b40e-71ae6c477d10.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dabigatran Etexilate	DABIGATRAN ETEXILATE	Ascend Laboratories, LLC	3a8ec82a-c367-40dc-9302-e1896fcb05ea	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208040 application number: ANDA208040
Dabigatran Etexilate	DABIGATRAN ETEXILATE	A-S Medication Solutions	b31d27e9-5502-43c5-83fa-89608c014b7a	2025-09-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208040 application number: ANDA208040
Dabigatran Etexilate	DABIGATRAN ETEXILATE	A-S Medication Solutions	369b945d-5bda-4773-910a-d0adef7f0f39	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208040 application number: ANDA208040
Dabigatran Etexilate	DABIGATRAN ETEXILATE	Major Pharmaceuticals	b76b79ce-b7dd-4390-b40e-71ae6c477d10	2025-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208040 application number: ANDA208040 ndc (product): 0904-7253

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	b76b79ce-b7dd-4390-b40e-71ae6c477d10	2
1037045	dabigatran etexilate 150 MG Oral Capsule	PSN	b76b79ce-b7dd-4390-b40e-71ae6c477d10	2
1037179	dabigatran etexilate 75 MG Oral Capsule	PSN	b76b79ce-b7dd-4390-b40e-71ae6c477d10	2
1723476	dabigatran etexilate 110 MG Oral Capsule	SCD	b76b79ce-b7dd-4390-b40e-71ae6c477d10	2
1037045	dabigatran etexilate 150 MG Oral Capsule	SCD	b76b79ce-b7dd-4390-b40e-71ae6c477d10	2
1037179	dabigatran etexilate 75 MG Oral Capsule	SCD	b76b79ce-b7dd-4390-b40e-71ae6c477d10	2
1723476	dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral Capsule	SY	b76b79ce-b7dd-4390-b40e-71ae6c477d10	2
1037045	dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral Capsule	SY	b76b79ce-b7dd-4390-b40e-71ae6c477d10	2
1037179	dabigatran etexilate 75 MG (as dabigatran etexilate mesylate 86.48 MG) Oral Capsule	SY	b76b79ce-b7dd-4390-b40e-71ae6c477d10	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0904-7253-04	00904725304	3 BLISTER PACK in 1 CARTON (0904-7253-04) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35)	3 blister pack	2025-06-23	No	No	Current
0904-7253-35	00904725335	10 in 1 BLISTER PACK					Historical
0904-7253-68	00904725368	6 BLISTER PACK in 1 CARTON (0904-7253-68) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35)	6 blister pack	2025-06-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dabigatran Etexilate	Major Pharmaceuticals \| Alkem Laboratories Limited	2025-06-12	Human Prescription Drug Label	2