FDA.reportPublic FDA data

Pradaxa

Product NDC
0597-0435
11-digit product format
005970435
Labeler code
0597
Product ID
0597-0435_56b1a7c2-0afd-40c6-bda5-563e234a9f28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dabigatran etexilate
Dosage form
PELLET
Route
ORAL
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Application
NDA214358
Marketing category
NDA
Marketing start
2022-03-16
Substance
DABIGATRAN ETEXILATE MESYLATE
Active strength
40 mg/1
Pharmacologic classes
Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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): 0597-0435

Additional Listing Data#

Finished product
Yes
Brand name base
Pradaxa
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DABIGATRAN ETEXILATE MESYLATE40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SC7NUW5IITInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2590616Internal RxNorm lookup
2590619Internal RxNorm lookup
2590620Internal RxNorm lookup
2590621Internal RxNorm lookup
2590623Internal RxNorm lookup
2590625Internal RxNorm lookup
2590627Internal RxNorm lookup
2590629Internal RxNorm lookup
2590631Internal RxNorm lookup
2590633Internal RxNorm lookup
2590635Internal RxNorm lookup
2590637Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9ac0a64a-8666-45f7-9d4f-40fd894f7e6dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
eb3de627-dc34-4a6a-871e-eb129f31c153Product name520260303
38a612c3-e18f-450b-8874-6e78282bc5f1Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0597-0435-96Pradaxa60 in 1 BAGPELLET607
0597-0435-96Pradaxa1 in 1 CARTONPELLET17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0435-96EA - Each0597-04353caa8342-b387-46ba-8582-7e84cef78cb812023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0435PRADAXA (DABIGATRAN ETEXILATE) PELLET [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 package rows20231129_9ac0a64a-8666-45f7-9d4f-40fd894f7e6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2590616dabigatran etexilate 110 MG Oral PelletPSN9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590620dabigatran etexilate 150 MG Oral PelletPSN9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590623dabigatran etexilate 20 MG Oral PelletPSN9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590627dabigatran etexilate 30 MG Oral PelletPSN9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590631dabigatran etexilate 40 MG Oral PelletPSN9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590635dabigatran etexilate 50 MG Oral PelletPSN9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590619Pradaxa 110 MG Oral PelletPSN9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590621Pradaxa 150 MG Oral PelletPSN9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590625Pradaxa 20 MG Oral PelletPSN9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590629Pradaxa 30 MG Oral PelletPSN9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590633Pradaxa 40 MG Oral PelletPSN9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590637Pradaxa 50 MG Oral PelletPSN9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590619dabigatran etexilate 110 MG Oral Pellet [Pradaxa]SBD9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590621dabigatran etexilate 150 MG Oral Pellet [Pradaxa]SBD9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590625dabigatran etexilate 20 MG Oral Pellet [Pradaxa]SBD9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590629dabigatran etexilate 30 MG Oral Pellet [Pradaxa]SBD9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590633dabigatran etexilate 40 MG Oral Pellet [Pradaxa]SBD9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590637dabigatran etexilate 50 MG Oral Pellet [Pradaxa]SBD9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590616dabigatran etexilate 110 MG Oral PelletSCD9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590620dabigatran etexilate 150 MG Oral PelletSCD9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590623dabigatran etexilate 20 MG Oral PelletSCD9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590627dabigatran etexilate 30 MG Oral PelletSCD9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590631dabigatran etexilate 40 MG Oral PelletSCD9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590635dabigatran etexilate 50 MG Oral PelletSCD9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590616dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral PelletSY9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590620dabigatran etexilate 150 MG (as dabigatran etexilate mesylate 172.95 MG) Oral PelletSY9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590623dabigatran etexilate 20 MG (as dabigatran etexilate mesylate 23.06 MG) Oral PelletSY9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590627dabigatran etexilate 30 MG (as dabigatran etexilate mesylate 34.59 MG) Oral PelletSY9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590631dabigatran etexilate 40 MG (as dabigatran etexilate mesylate 46.12 MG) Oral PelletSY9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590635dabigatran etexilate 50 MG (as dabigatran etexilate mesylate 57.65 MG) Oral PelletSY9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590619Pradaxa 110 MG Oral PelletSY9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590621Pradaxa 150 MG Oral PelletSY9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590625Pradaxa 20 MG Oral PelletSY9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590629Pradaxa 30 MG Oral PelletSY9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590633Pradaxa 40 MG Oral PelletSY9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7
2590637Pradaxa 50 MG Oral PelletSY9ac0a64a-8666-45f7-9d4f-40fd894f7e6d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0435-96005970435961 BAG in 1 CARTON (0597-0435-96) / 60 PELLET in 1 BAG1 bag2022-03-160000-00-00NoNoCurrent