Home NDC 0378-0266 Dabigatran Etexilate
Product NDC 0378-0266
11-digit product format 003780266
Labeler code 0378
Product ID 0378-0266_6c6b985e-111f-4fe9-a1ca-785c450e444b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dabigatran Etexilate
Dosage form CAPSULE
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA208067
Marketing category ANDA
Marketing start 2025-02-25
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208067-001 DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2025-02-03 A208067-002 DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2025-02-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2026-02-19 14:30 UTC 2026-02 A208067-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2025-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208067-002 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2025-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208067-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2025-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208067-002 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2025-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208067-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2025-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208067-002 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2025-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208067-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2025-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208067-002 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2025-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208067-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2025-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208067-002 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2025-02-03 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208067-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2025-02-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208067-002 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2025-02-03 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1037045 Internal RxNorm lookup 1037179 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 0378-0266-91 Dabigatran Etexilate 60 in 1 BOTTLE, PLASTIC CAPSULE 60 4 0378-0266-93 Dabigatran Etexilate 30 in 1 BOTTLE, PLASTIC CAPSULE 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-0266 DABIGATRAN ETEXILATE CAPSULE [MYLAN PHARMACEUTICALS INC.] 3 Current NDC, 2 package rows 20250302_baafb5be-ffe6-4755-a7ab-817b3c9b222d.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0378-0266-91 00378026691 60 CAPSULE in 1 BOTTLE, PLASTIC (0378-0266-91) 60 capsule 2025-02-25 No No Current 0378-0266-93 00378026693 30 in 1 BOTTLE, PLASTIC Historical