Home NDC 50090-3617 Pradaxa
Product NDC 50090-3617
11-digit product format 500903617
Labeler code 50090
Product ID 50090-3617_76d95065-2155-4146-b551-d96f79612da0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dabigatran etexilate mesylate
Dosage form CAPSULE
Route ORAL
Labeler A-S Medication Solutions
Application NDA022512
Marketing category NDA
Marketing start 2017-07-28
Marketing end 0000-00-00
Substance DABIGATRAN ETEXILATE MESYLATE
Active strength 150 mg/1
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
Historic NDC status page 1 of 1 · 18 matching rows.
Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 50090-3617 I Inactivated by FDA excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-3617 50090-3617-0 I Inactivated by FDA excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product 50090-3617 I Inactivated by FDA excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-3617 50090-3617-0 I Inactivated by FDA excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 50090-3617 I Inactivated by FDA excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-3617 50090-3617-0 I Inactivated by FDA excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product 50090-3617 I Inactivated by FDA excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-3617 50090-3617-0 I Inactivated by FDA excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 50090-3617 I Inactivated by FDA excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-3617 50090-3617-0 I Inactivated by FDA excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 50090-3617 I Inactivated by FDA excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-3617 50090-3617-0 I Inactivated by FDA excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 50090-3617 I Inactivated by FDA excluded / ndc_excluded.zip 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-3617 50090-3617-0 I Inactivated by FDA excluded / ndc_excluded.zip 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 50090-3617 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-3617 50090-3617-0 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 50090-3617 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-3617 50090-3617-0 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# 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
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-3617-0 Pradaxa 60 in 1 BOTTLE CAPSULE 60 8 50090-3617-0 Pradaxa 1 in 1 CARTON CAPSULE 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-3617 PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [A-S MEDICATION SOLUTIONS] 8 Legacy NDC, 2 package rows 20210617_80637981-d5a7-48cb-b7b2-f50807a8ab20.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 50090-3617-0 50090361700 1 BOTTLE in 1 CARTON (50090-3617-0) > 60 CAPSULE in 1 BOTTLE 1 bottle 2018-10-05 0000-00-00 No No Current