Home NDC 59651-975 DABIGATRAN ETEXILATE
Product NDC 59651-975
11-digit product format 596510975
Labeler code 59651
Product ID 59651-975_4b36f34b-c19b-497d-9dd6-5c50404226c5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DABIGATRAN ETEXILATE
Dosage form CAPSULE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA208039
Marketing category ANDA
Marketing start 2025-05-14
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 RLD / RS Approval date A208039-001 DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2025-05-14 A208039-002 DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL AB 2025-05-14 A208039-003 DABIGATRAN ETEXILATE MESYLATE DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2025-05-14
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 2026-08-18 06:07:40 2026-07 A208039-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2025-05-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208039-002 DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL AB 2025-05-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208039-003 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2025-05-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208039-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2025-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208039-002 DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL AB 2025-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208039-003 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2025-05-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208039-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2025-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208039-002 DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL AB 2025-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208039-003 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2025-05-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208039-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2025-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208039-002 DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL AB 2025-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208039-003 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2025-05-14 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208039-001 DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB 2025-05-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208039-002 DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL AB 2025-05-14 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208039-003 DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2025-05-14 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 · 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 59651-975-60 DABIGATRAN ETEXILATE 60 in 1 BOTTLE CAPSULE 60 3 59651-975-61 DABIGATRAN ETEXILATE 10 in 1 CARTON CAPSULE 10 3 59651-975-61 DABIGATRAN ETEXILATE 6 in 1 BLISTER PACK CAPSULE 6 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-975 DABIGATRAN ETEXILATE CAPSULE [AUROBINDO PHARMA LIMITED] 1 Current NDC, 3 package rows 20250522_5b196b1f-408e-4615-b980-9f822adff835.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 59651-975-60 59651097560 60 CAPSULE in 1 BOTTLE (59651-975-60) 60 capsule 2025-05-14 No No Current 59651-975-61 59651097561 10 BLISTER PACK in 1 CARTON (59651-975-61) / 6 CAPSULE in 1 BLISTER PACK 10 blister pack 2025-05-14 No No Current