Home NDC 0597-0108 Pradaxa
Product NDC 0597-0108
11-digit product format 005970108
Labeler code 0597
Product ID 0597-0108_ecf1aa06-c610-4fdb-a380-2e716d7e63c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dabigatran etexilate mesylate
Dosage form CAPSULE
Route ORAL
Labeler Boehringer Ingelheim Pharmaceuticals Inc.
Application NDA022512
Marketing category NDA
Marketing start 2015-11-23
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 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 N022512-001 PRADAXA DABIGATRAN ETEXILATE MESYLATE EQ 75MG BASE CAPSULE / ORAL AB RLD 2010-10-19 N022512-002 PRADAXA DABIGATRAN ETEXILATE MESYLATE EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2010-10-19 N022512-003 PRADAXA DABIGATRAN ETEXILATE MESYLATE EQ 110MG BASE CAPSULE / ORAL AB RLD 2015-11-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 12 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022512-001 7932273 2025-09-07 Drug substance, Drug product 2011-08-01 N022512-001 7932273*PED 2026-03-07 Pediatric extension N022512-001 9034822 2031-01-20 U-1759 2015-11-09 N022512-001 9034822*PED 2031-07-20 Pediatric extension N022512-002 7932273 2025-09-07 Drug substance, Drug product N022512-002 7932273*PED 2026-03-07 Pediatric extension N022512-002 9034822 2031-01-20 U-1759 2015-11-09 N022512-002 9034822*PED 2031-07-20 Pediatric extension N022512-003 7932273 2025-09-07 Drug substance, Drug product 2015-12-15 N022512-003 7932273*PED 2026-03-07 Pediatric extension N022512-003 9034822 2031-01-20 U-1759 2015-12-15 N022512-003 9034822*PED 2031-07-20 Pediatric extension
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 N022512-001 PRADAXA EQ 75MG BASE CAPSULE / ORAL AB RLD 2010-10-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N022512-002 PRADAXA EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2010-10-19 a50c72e98297…2026-08-01 22:54:32 2026-06 N022512-003 PRADAXA EQ 110MG BASE CAPSULE / ORAL AB RLD 2015-11-20 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N022512-001 7932273 2025-09-07 Drug substance, Drug product 2011-08-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N022512-001 7932273*PED 2026-03-07 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022512-001 9034822 2031-01-20 U-1759 2015-11-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N022512-001 9034822*PED 2031-07-20 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022512-002 7932273 2025-09-07 Drug substance, Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022512-002 7932273*PED 2026-03-07 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022512-002 9034822 2031-01-20 U-1759 2015-11-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N022512-002 9034822*PED 2031-07-20 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022512-003 7932273 2025-09-07 Drug substance, Drug product 2015-12-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N022512-003 7932273*PED 2026-03-07 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022512-003 9034822 2031-01-20 U-1759 2015-12-15 a50c72e98297…2026-08-01 22:54:32 2026-06 N022512-003 9034822*PED 2031-07-20 Pediatric extension a50c72e98297…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pradaxa DABIGATRAN ETEXILATE MESYLATE Boehringer Ingelheim Pharmaceuticals Inc. ba74e3cd-b06f-4145-b284-5fd6b84ff3c9 2025-06-25 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022512 application number: NDA022512 ndc (product): 0597-0108
Additional Listing Data#
Finished product Yes
Brand name base Pradaxa
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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1037045 Internal RxNorm lookup 1037049 Internal RxNorm lookup 1037179 Internal RxNorm lookup 1037181 Internal RxNorm lookup 1723476 Internal RxNorm lookup 1723478 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0597-0108 PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.] 47 Current NDC, Legacy NDC, 4 package rows 20231201_ba74e3cd-b06f-4145-b284-5fd6b84ff3c9.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0597-0108-54 00597010854 1 BOTTLE in 1 CARTON (0597-0108-54) / 60 CAPSULE in 1 BOTTLE 1 bottle 2017-07-07 0000-00-00 No No Current 0597-0108-60 00597010860 10 BLISTER PACK in 1 CARTON (0597-0108-60) / 6 CAPSULE in 1 BLISTER PACK 10 blister pack 2015-11-23 0000-00-00 No No Current