FDA.reportPublic FDA data

Application 214358

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRADAXADABIGATRANPELLETS;ORAL20MGNoNo
002PRADAXADABIGATRANPELLETS;ORAL30MGNoNo
003PRADAXADABIGATRANPELLETS;ORAL40MGNoNo
004PRADAXADABIGATRANPELLETS;ORAL50MGNoNo
005PRADAXADABIGATRANPELLETS;ORAL110MGNoNo
006PRADAXADABIGATRANPELLETS;ORAL150MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N214358-001PRADAXADABIGATRAN ETEXILATE MESYLATEEQ 20MG BASE/PACKETPELLETS / ORALRLD2021-06-21
N214358-002PRADAXADABIGATRAN ETEXILATE MESYLATEEQ 30MG BASE/PACKETPELLETS / ORALRLD2021-06-21
N214358-003PRADAXADABIGATRAN ETEXILATE MESYLATEEQ 40MG BASE/PACKETPELLETS / ORALRLD2021-06-21
N214358-004PRADAXADABIGATRAN ETEXILATE MESYLATEEQ 50MG BASE/PACKETPELLETS / ORALRLD2021-06-21
N214358-005PRADAXADABIGATRAN ETEXILATE MESYLATEEQ 110MG BASE/PACKETPELLETS / ORALRLD2021-06-21
N214358-006PRADAXADABIGATRAN ETEXILATE MESYLATEEQ 150MG BASE/PACKETPELLETS / ORALRLD, RS2021-06-21

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N214358-00179322732025-09-07Drug substance, Drug product2021-07-28
N214358-0017932273*PED2026-03-07Pediatric extension
N214358-00279322732025-09-07Drug substance, Drug product2021-07-28
N214358-0027932273*PED2026-03-07Pediatric extension
N214358-00379322732025-09-07Drug substance, Drug product2021-07-28
N214358-0037932273*PED2026-03-07Pediatric extension
N214358-00479322732025-09-07Drug substance, Drug product2021-07-28
N214358-0047932273*PED2026-03-07Pediatric extension
N214358-00579322732025-09-07Drug substance, Drug product2021-07-28
N214358-0057932273*PED2026-03-07Pediatric extension
N214358-00679322732025-09-07Drug substance, Drug product2021-07-28
N214358-0067932273*PED2026-03-07Pediatric 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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N214358-001PRADAXAEQ 20MG BASE/PACKETPELLETS / ORALRLD2021-06-21a50c72e98297…
2026-08-01 22:54:322026-06N214358-002PRADAXAEQ 30MG BASE/PACKETPELLETS / ORALRLD2021-06-21a50c72e98297…
2026-08-01 22:54:322026-06N214358-003PRADAXAEQ 40MG BASE/PACKETPELLETS / ORALRLD2021-06-21a50c72e98297…
2026-08-01 22:54:322026-06N214358-004PRADAXAEQ 50MG BASE/PACKETPELLETS / ORALRLD2021-06-21a50c72e98297…
2026-08-01 22:54:322026-06N214358-005PRADAXAEQ 110MG BASE/PACKETPELLETS / ORALRLD2021-06-21a50c72e98297…
2026-08-01 22:54:322026-06N214358-006PRADAXAEQ 150MG BASE/PACKETPELLETS / ORALRLD, RS2021-06-21a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N214358-00179322732025-09-07Drug substance, Drug product2021-07-28a50c72e98297…
2026-08-01 22:54:322026-06N214358-0017932273*PED2026-03-07Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N214358-00279322732025-09-07Drug substance, Drug product2021-07-28a50c72e98297…
2026-08-01 22:54:322026-06N214358-0027932273*PED2026-03-07Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N214358-00379322732025-09-07Drug substance, Drug product2021-07-28a50c72e98297…
2026-08-01 22:54:322026-06N214358-0037932273*PED2026-03-07Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N214358-00479322732025-09-07Drug substance, Drug product2021-07-28a50c72e98297…
2026-08-01 22:54:322026-06N214358-0047932273*PED2026-03-07Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N214358-00579322732025-09-07Drug substance, Drug product2021-07-28a50c72e98297…
2026-08-01 22:54:322026-06N214358-0057932273*PED2026-03-07Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N214358-00679322732025-09-07Drug substance, Drug product2021-07-28a50c72e98297…
2026-08-01 22:54:322026-06N214358-0067932273*PED2026-03-07Pediatric extensiona50c72e98297…

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 ETEXILATEBoehringer Ingelheim Pharmaceuticals, Inc.9ac0a64a-8666-45f7-9d4f-40fd894f7e6d2025-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 214358
application number: NDA214358
ndc (product): 0597-0430
ndc (product): 0597-0435
ndc (product): 0597-0425
ndc (product): 0597-0445
ndc (product): 0597-0450
ndc (product): 0597-0440

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0425PradaxaDABIGATRAN ETEXILATE MESYLATEBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0425Pradaxadabigatran etexilateBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0425Pradaxadabigatran etexilateBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0430PradaxaDABIGATRAN ETEXILATE MESYLATEBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0430Pradaxadabigatran etexilateBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0430Pradaxadabigatran etexilateBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0435PradaxaDABIGATRAN ETEXILATE MESYLATEBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0435Pradaxadabigatran etexilateBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0435Pradaxadabigatran etexilateBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0440PradaxaDABIGATRAN ETEXILATE MESYLATEBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0440Pradaxadabigatran etexilateBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0440Pradaxadabigatran etexilateBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0445PradaxaDABIGATRAN ETEXILATE MESYLATEBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0445Pradaxadabigatran etexilateBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0445Pradaxadabigatran etexilateBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0450PradaxaDABIGATRAN ETEXILATE MESYLATEBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0450Pradaxadabigatran etexilateBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0450Pradaxadabigatran etexilateBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83643SUPPL 2025-10-03
82604SUPPL 2025-10-03
82605SUPPL 2025-06-20
76575SUPPL 2023-11-15
76570SUPPL 2023-11-15
70698SUPPL2022-04-05
70697SUPPL2022-04-05
70678ORIG2022-04-01
70630SUPPL2022-03-28
67871ORIG2021-06-23
67847ORIG2021-06-22
67846ORIG2021-06-22