Home NDC 0597-0149 Pradaxa
Product NDC 0597-0149
11-digit product format 005970149
Labeler code 0597
Product ID 0597-0149_089eda8b-0f51-c567-37a7-6412754b1ff5
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 2011-08-08
Marketing end 0000-00-00
Substance DABIGATRAN ETEXILATE MESYLATE
Active strength 75 mg/1
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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