Home NDC 0904-7255 Dabigatran Etexilate
Product NDC 0904-7255
11-digit product format 009047255
Labeler code 0904
Product ID 0904-7255_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 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 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 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.
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 2026-08-01 22:54:32 2026-06 A208040-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2020-03-11 a50c72e98297…2026-08-01 22:54:32 2026-06 A208040-002 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2020-03-11 a50c72e98297…2026-08-01 22:54:32 2026-06 A208040-003 DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL AB 2024-09-11 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Ascend Laboratories, LLC 3a8ec82a-c367-40dc-9302-e1896fcb05ea 2025-09-17 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): 0904-7255
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 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 · 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 0904-7255-10 Dabigatran Etexilate 2 in 1 CARTON CAPSULE, COATED PELLETS 2 2 0904-7255-35 Dabigatran Etexilate 10 in 1 BLISTER PACK CAPSULE, COATED PELLETS 10 2 0904-7255-68 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 0904-7255 DABIGATRAN ETEXILATE CAPSULE, COATED PELLETS [MAJOR PHARMACEUTICALS] 1 Current NDC, 3 package rows 20250515_b76b79ce-b7dd-4390-b40e-71ae6c477d10.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0904-7255-10 00904725510 2 BLISTER PACK in 1 CARTON (0904-7255-10) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7255-35) 2 blister pack 2025-06-23 No No Current 0904-7255-35 00904725535 10 in 1 BLISTER PACK Historical 0904-7255-68 00904725568 6 BLISTER PACK in 1 CARTON (0904-7255-68) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7255-35) 6 blister pack 2025-06-23 No No Current