Home NDC 0904-7254 Dabigatran Etexilate
Product NDC 0904-7254
11-digit product format 009047254
Labeler code 0904
Product ID 0904-7254_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 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 43 .
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 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.
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 · 91 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 2026-09-14 22:38:34 2026-08 A208040-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2020-03-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208040-002 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2020-03-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208040-003 DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL AB 2024-09-11 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 91 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-7254-35 Dabigatran Etexilate 10 in 1 BLISTER PACK CAPSULE, COATED PELLETS 10 2 0904-7254-68 Dabigatran Etexilate 6 in 1 CARTON CAPSULE, COATED PELLETS 6 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7254 DABIGATRAN ETEXILATE CAPSULE, COATED PELLETS [MAJOR PHARMACEUTICALS] 1 Current NDC, 2 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): 0904-7254
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0904-7254-35 00904725435 10 in 1 BLISTER PACK Historical 0904-7254-68 00904725468 6 BLISTER PACK in 1 CARTON (0904-7254-68) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7254-35) 6 blister pack 2025-06-23 No No Current