Home NDC 63629-8242 Pradaxa
Product NDC 63629-8242
11-digit product format 636298242
Labeler code 63629
Product ID 63629-8242_1a214cf1-b41e-46f6-8f24-e3637e6d2612
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dabigatran etexilate mesylate
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA022512
Marketing category NDA
Marketing start 2017-07-28
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 63629-8242 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 63629-8242 63629-8242-1 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
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.
Product history page 1 of 4 · 123 observed 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 N022512-001 PRADAXA EQ 75MG BASE CAPSULE / ORAL AB RLD 2010-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022512-002 PRADAXA EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2010-10-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022512-003 PRADAXA EQ 110MG BASE CAPSULE / ORAL AB RLD 2015-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022512-001 PRADAXA EQ 75MG BASE CAPSULE / ORAL AB RLD 2010-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022512-002 PRADAXA EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2010-10-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022512-003 PRADAXA EQ 110MG BASE CAPSULE / ORAL AB RLD 2015-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022512-001 PRADAXA EQ 75MG BASE CAPSULE / ORAL AB RLD 2010-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022512-002 PRADAXA EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2010-10-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022512-003 PRADAXA EQ 110MG BASE CAPSULE / ORAL AB RLD 2015-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022512-001 PRADAXA EQ 75MG BASE CAPSULE / ORAL AB RLD 2010-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022512-002 PRADAXA EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2010-10-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022512-003 PRADAXA EQ 110MG BASE CAPSULE / ORAL AB RLD 2015-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022512-001 PRADAXA EQ 75MG BASE CAPSULE / ORAL AB RLD 2010-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022512-002 PRADAXA EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2010-10-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022512-003 PRADAXA EQ 110MG BASE CAPSULE / ORAL AB RLD 2015-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022512-001 PRADAXA EQ 75MG BASE CAPSULE / ORAL AB RLD 2010-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022512-002 PRADAXA EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2010-10-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022512-003 PRADAXA EQ 110MG BASE CAPSULE / ORAL AB RLD 2015-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022512-001 PRADAXA EQ 75MG BASE CAPSULE / ORAL AB RLD 2010-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022512-002 PRADAXA EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2010-10-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022512-003 PRADAXA EQ 110MG BASE CAPSULE / ORAL AB RLD 2015-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022512-001 PRADAXA EQ 75MG BASE CAPSULE / ORAL AB RLD 2010-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022512-002 PRADAXA EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2010-10-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022512-003 PRADAXA EQ 110MG BASE CAPSULE / ORAL AB RLD 2015-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022512-001 PRADAXA EQ 75MG BASE CAPSULE / ORAL AB RLD 2010-10-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022512-002 PRADAXA EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2010-10-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022512-003 PRADAXA EQ 110MG BASE CAPSULE / ORAL AB RLD 2015-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022512-001 PRADAXA EQ 75MG BASE CAPSULE / ORAL AB RLD 2010-10-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022512-002 PRADAXA EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2010-10-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022512-003 PRADAXA EQ 110MG BASE CAPSULE / ORAL AB RLD 2015-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022512-001 PRADAXA EQ 75MG BASE CAPSULE / ORAL AB RLD 2010-10-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022512-002 PRADAXA EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2010-10-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022512-003 PRADAXA EQ 110MG BASE CAPSULE / ORAL AB RLD 2015-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022512-001 PRADAXA EQ 75MG BASE CAPSULE / ORAL AB RLD 2010-10-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022512-002 PRADAXA EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2010-10-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022512-003 PRADAXA EQ 110MG BASE CAPSULE / ORAL AB RLD 2015-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022512-001 PRADAXA EQ 75MG BASE CAPSULE / ORAL AB RLD 2010-10-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022512-002 PRADAXA EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2010-10-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022512-003 PRADAXA EQ 110MG BASE CAPSULE / ORAL AB RLD 2015-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022512-001 PRADAXA EQ 75MG BASE CAPSULE / ORAL AB RLD 2010-10-19 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 91 observed states.
Observed Orange Book patent history# Patent history page 1 of 20 · 770 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022512-001 7932273 2025-09-07 Drug substance, Drug product 2011-08-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022512-001 7932273*PED 2026-03-07 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022512-001 9034822 2031-01-20 U-1759 2015-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022512-001 9034822*PED 2031-07-20 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022512-002 7932273 2025-09-07 Drug substance, Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022512-002 7932273*PED 2026-03-07 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022512-002 9034822 2031-01-20 U-1759 2015-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022512-002 9034822*PED 2031-07-20 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022512-003 7932273 2025-09-07 Drug substance, Drug product 2015-12-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022512-003 7932273*PED 2026-03-07 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022512-003 9034822 2031-01-20 U-1759 2015-12-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022512-003 9034822*PED 2031-07-20 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022512-001 7932273 2025-09-07 Drug substance, Drug product 2011-08-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022512-001 7932273*PED 2026-03-07 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022512-001 9034822 2031-01-20 U-1759 2015-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022512-001 9034822*PED 2031-07-20 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022512-002 7932273 2025-09-07 Drug substance, Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022512-002 7932273*PED 2026-03-07 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022512-002 9034822 2031-01-20 U-1759 2015-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022512-002 9034822*PED 2031-07-20 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022512-003 7932273 2025-09-07 Drug substance, Drug product 2015-12-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022512-003 7932273*PED 2026-03-07 Pediatric extension 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022512-003 9034822 2031-01-20 U-1759 2015-12-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022512-003 9034822*PED 2031-07-20 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022512-001 7932273 2025-09-07 Drug substance, Drug product 2011-08-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022512-001 7932273*PED 2026-03-07 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022512-001 9034822 2031-01-20 U-1759 2015-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022512-001 9034822*PED 2031-07-20 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022512-002 7932273 2025-09-07 Drug substance, Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022512-002 7932273*PED 2026-03-07 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022512-002 9034822 2031-01-20 U-1759 2015-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022512-002 9034822*PED 2031-07-20 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022512-003 7932273 2025-09-07 Drug substance, Drug product 2015-12-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022512-003 7932273*PED 2026-03-07 Pediatric extension 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022512-003 9034822 2031-01-20 U-1759 2015-12-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022512-003 9034822*PED 2031-07-20 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022512-001 7932273 2025-09-07 Drug substance, Drug product 2011-08-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022512-001 7932273*PED 2026-03-07 Pediatric extension fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022512-001 9034822 2031-01-20 U-1759 2015-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022512-001 9034822*PED 2031-07-20 Pediatric extension fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 162 observed states.
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.
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
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-8242 PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [BRYANT RANCH PREPACK] 3 Legacy NDC 20240511_1a214cf1-b41e-46f6-8f24-e3637e6d2612.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-8242-1 63629824201 30 CAPSULE in 1 BOTTLE (63629-8242-1) 30 capsule 2019-09-10 0000-00-00 No No Current