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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-3617IInactivated by FDA2026-08-03
excluded packagepackage50090-361750090-3617-0IInactivated by FDA2026-08-03

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct50090-3617IInactivated by FDAexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-361750090-3617-0IInactivated by FDAexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct50090-3617IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-361750090-3617-0IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct50090-3617IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-361750090-3617-0IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct50090-3617IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-361750090-3617-0IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct50090-3617IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-361750090-3617-0IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct50090-3617IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-361750090-3617-0IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct50090-3617IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-361750090-3617-0IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct50090-3617IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-361750090-3617-0IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct50090-3617IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-361750090-3617-0IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022512-001PRADAXADABIGATRAN ETEXILATE MESYLATEEQ 75MG BASECAPSULE / ORALABRLD2010-10-19
N022512-002PRADAXADABIGATRAN ETEXILATE MESYLATEEQ 150MG BASECAPSULE / ORALABRLD, RS2010-10-19
N022512-003PRADAXADABIGATRAN ETEXILATE MESYLATEEQ 110MG BASECAPSULE / ORALABRLD2015-11-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N022512-001AB
N022512-002AB
N022512-003AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022512-00179322732025-09-07Drug substance, Drug product2011-08-01
N022512-0017932273*PED2026-03-07Pediatric extension
N022512-00190348222031-01-20U-17592015-11-09
N022512-0019034822*PED2031-07-20Pediatric extension
N022512-00279322732025-09-07Drug substance, Drug product
N022512-0027932273*PED2026-03-07Pediatric extension
N022512-00290348222031-01-20U-17592015-11-09
N022512-0029034822*PED2031-07-20Pediatric extension
N022512-00379322732025-09-07Drug substance, Drug product2015-12-15
N022512-0037932273*PED2026-03-07Pediatric extension
N022512-00390348222031-01-20U-17592015-12-15
N022512-0039034822*PED2031-07-20Pediatric 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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022512-001PRADAXAEQ 75MG BASECAPSULE / ORALABRLD2010-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022512-002PRADAXAEQ 150MG BASECAPSULE / ORALABRLD, RS2010-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022512-003PRADAXAEQ 110MG BASECAPSULE / ORALABRLD2015-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022512-001PRADAXAEQ 75MG BASECAPSULE / ORALABRLD2010-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022512-002PRADAXAEQ 150MG BASECAPSULE / ORALABRLD, RS2010-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022512-003PRADAXAEQ 110MG BASECAPSULE / ORALABRLD2015-11-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N022512-001PRADAXAEQ 75MG BASECAPSULE / ORALABRLD2010-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022512-002PRADAXAEQ 150MG BASECAPSULE / ORALABRLD, RS2010-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022512-003PRADAXAEQ 110MG BASECAPSULE / ORALABRLD2015-11-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022512-001PRADAXAEQ 75MG BASECAPSULE / ORALABRLD2010-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022512-002PRADAXAEQ 150MG BASECAPSULE / ORALABRLD, RS2010-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022512-003PRADAXAEQ 110MG BASECAPSULE / ORALABRLD2015-11-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022512-001PRADAXAEQ 75MG BASECAPSULE / ORALABRLD2010-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022512-002PRADAXAEQ 150MG BASECAPSULE / ORALABRLD, RS2010-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022512-003PRADAXAEQ 110MG BASECAPSULE / ORALABRLD2015-11-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022512-001PRADAXAEQ 75MG BASECAPSULE / ORALABRLD2010-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022512-002PRADAXAEQ 150MG BASECAPSULE / ORALABRLD, RS2010-10-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022512-003PRADAXAEQ 110MG BASECAPSULE / ORALABRLD2015-11-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022512-001PRADAXAEQ 75MG BASECAPSULE / ORALABRLD2010-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022512-002PRADAXAEQ 150MG BASECAPSULE / ORALABRLD, RS2010-10-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022512-003PRADAXAEQ 110MG BASECAPSULE / ORALABRLD2015-11-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022512-001PRADAXAEQ 75MG BASECAPSULE / ORALABRLD2010-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022512-002PRADAXAEQ 150MG BASECAPSULE / ORALABRLD, RS2010-10-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022512-003PRADAXAEQ 110MG BASECAPSULE / ORALABRLD2015-11-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022512-001PRADAXAEQ 75MG BASECAPSULE / ORALABRLD2010-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022512-002PRADAXAEQ 150MG BASECAPSULE / ORALABRLD, RS2010-10-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022512-003PRADAXAEQ 110MG BASECAPSULE / ORALABRLD2015-11-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022512-001PRADAXAEQ 75MG BASECAPSULE / ORALABRLD2010-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N022512-002PRADAXAEQ 150MG BASECAPSULE / ORALABRLD, RS2010-10-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N022512-003PRADAXAEQ 110MG BASECAPSULE / ORALABRLD2015-11-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022512-001PRADAXAEQ 75MG BASECAPSULE / ORALABRLD2010-10-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022512-002PRADAXAEQ 150MG BASECAPSULE / ORALABRLD, RS2010-10-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022512-003PRADAXAEQ 110MG BASECAPSULE / ORALABRLD2015-11-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022512-001PRADAXAEQ 75MG BASECAPSULE / ORALABRLD2010-10-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022512-002PRADAXAEQ 150MG BASECAPSULE / ORALABRLD, RS2010-10-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022512-003PRADAXAEQ 110MG BASECAPSULE / ORALABRLD2015-11-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022512-001PRADAXAEQ 75MG BASECAPSULE / ORALABRLD2010-10-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022512-002PRADAXAEQ 150MG BASECAPSULE / ORALABRLD, RS2010-10-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022512-003PRADAXAEQ 110MG BASECAPSULE / ORALABRLD2015-11-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022512-001PRADAXAEQ 75MG BASECAPSULE / ORALABRLD2010-10-198072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 91 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N022512-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022512-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022512-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022512-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022512-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022512-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022512-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022512-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022512-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022512-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022512-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022512-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022512-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022512-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022512-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022512-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022512-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022512-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022512-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022512-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022512-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022512-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022512-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022512-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022512-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022512-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022512-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022512-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N022512-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N022512-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022512-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022512-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022512-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022512-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022512-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022512-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022512-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022512-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022512-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022512-001AB18072bd15b7f6…

Observed Orange Book patent history#

Patent history page 1 of 20 · 770 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022512-00179322732025-09-07Drug substance, Drug product2011-08-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022512-0017932273*PED2026-03-07Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022512-00190348222031-01-20U-17592015-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022512-0019034822*PED2031-07-20Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022512-00279322732025-09-07Drug substance, Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022512-0027932273*PED2026-03-07Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022512-00290348222031-01-20U-17592015-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022512-0029034822*PED2031-07-20Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022512-00379322732025-09-07Drug substance, Drug product2015-12-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022512-0037932273*PED2026-03-07Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022512-00390348222031-01-20U-17592015-12-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022512-0039034822*PED2031-07-20Pediatric extension011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022512-00179322732025-09-07Drug substance, Drug product2011-08-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022512-0017932273*PED2026-03-07Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022512-00190348222031-01-20U-17592015-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022512-0019034822*PED2031-07-20Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022512-00279322732025-09-07Drug substance, Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022512-0027932273*PED2026-03-07Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022512-00290348222031-01-20U-17592015-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022512-0029034822*PED2031-07-20Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022512-00379322732025-09-07Drug substance, Drug product2015-12-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022512-0037932273*PED2026-03-07Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022512-00390348222031-01-20U-17592015-12-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022512-0039034822*PED2031-07-20Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N022512-00179322732025-09-07Drug substance, Drug product2011-08-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022512-0017932273*PED2026-03-07Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022512-00190348222031-01-20U-17592015-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022512-0019034822*PED2031-07-20Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022512-00279322732025-09-07Drug substance, Drug product6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022512-0027932273*PED2026-03-07Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022512-00290348222031-01-20U-17592015-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022512-0029034822*PED2031-07-20Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022512-00379322732025-09-07Drug substance, Drug product2015-12-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022512-0037932273*PED2026-03-07Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022512-00390348222031-01-20U-17592015-12-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022512-0039034822*PED2031-07-20Pediatric extension6a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022512-00179322732025-09-07Drug substance, Drug product2011-08-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022512-0017932273*PED2026-03-07Pediatric extensionfd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022512-00190348222031-01-20U-17592015-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022512-0019034822*PED2031-07-20Pediatric extensionfd3edfee7708…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 162 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022512-001I-8622024-06-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022512-001PED2024-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022512-002I-8622024-06-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022512-002PED2024-12-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022512-003I-8622024-06-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022512-003PED2024-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022512-001I-8622024-06-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022512-001PED2024-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022512-002I-8622024-06-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022512-002PED2024-12-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022512-003I-8622024-06-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022512-003PED2024-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022512-001I-8622024-06-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022512-001PED2024-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022512-002I-8622024-06-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022512-002PED2024-12-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022512-003I-8622024-06-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022512-003PED2024-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022512-001I-8622024-06-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022512-001PED2024-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022512-002I-8622024-06-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022512-002PED2024-12-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022512-003I-8622024-06-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022512-003PED2024-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022512-001I-8622024-06-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N022512-001PED2024-12-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N022512-002I-8622024-06-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N022512-002PED2024-12-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N022512-003I-8622024-06-21d06236e962d9…
2024-10-29 15:01 UTC2024-10N022512-003PED2024-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022512-001I-8622024-06-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022512-001PED2024-12-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022512-002I-8622024-06-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022512-002PED2024-12-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022512-003I-8622024-06-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022512-003PED2024-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022512-001I-8622024-06-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022512-001PED2024-12-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022512-002I-8622024-06-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022512-002PED2024-12-21301d65b070ca…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PradaxaDABIGATRAN ETEXILATE MESYLATEBoehringer Ingelheim Pharmaceuticals Inc.ba74e3cd-b06f-4145-b284-5fd6b84ff3c92025-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022512
application number: NDA022512

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
eb3de627-dc34-4a6a-871e-eb129f31c153Product name520260303
38a612c3-e18f-450b-8874-6e78282bc5f1Product name120220118

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3617-0Pradaxa60 in 1 BOTTLECAPSULE608
50090-3617-0Pradaxa1 in 1 CARTONCAPSULE18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3617PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [A-S MEDICATION SOLUTIONS]8Legacy NDC, 2 package rows20210617_80637981-d5a7-48cb-b7b2-f50807a8ab20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1037045dabigatran etexilate 150 MG Oral CapsulePSN80637981-d5a7-48cb-b7b2-f50807a8ab208
1037049Pradaxa 150 MG Oral CapsulePSN80637981-d5a7-48cb-b7b2-f50807a8ab208
1037049dabigatran etexilate 150 MG Oral Capsule [Pradaxa]SBD80637981-d5a7-48cb-b7b2-f50807a8ab208
1037045dabigatran etexilate 150 MG Oral CapsuleSCD80637981-d5a7-48cb-b7b2-f50807a8ab208
1037045dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral CapsuleSY80637981-d5a7-48cb-b7b2-f50807a8ab208
1037049Pradaxa 150 MG (as dabigatran etexilate mesylate 172.95 MG) Oral CapsuleSY80637981-d5a7-48cb-b7b2-f50807a8ab208
1037049Pradaxa 150 MG Oral CapsuleSY80637981-d5a7-48cb-b7b2-f50807a8ab208

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3617-0500903617001 BOTTLE in 1 CARTON (50090-3617-0) > 60 CAPSULE in 1 BOTTLE1 bottle2018-10-050000-00-00NoNoCurrent