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 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 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 2026-02-19 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# 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 · 1 matching rows.
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
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