FDA.reportPublic FDA data

Pradaxa

Product NDC
0597-0360
11-digit product format
005970360
Labeler code
0597
Product ID
0597-0360_ecf1aa06-c610-4fdb-a380-2e716d7e63c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dabigatran etexilate mesylate
Dosage form
CAPSULE
Route
ORAL
Labeler
Boehringer Ingelheim Pharmaceuticals Inc.
Application
NDA022512
Marketing category
NDA
Marketing start
2017-07-28
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
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0597-03600597-0360-42DDiscontinued by firm2026-08-03

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N022512-001PRADAXAEQ 75MG BASECAPSULE / ORALABRLD2010-10-19a50c72e98297…
2026-08-01 22:54:322026-06N022512-002PRADAXAEQ 150MG BASECAPSULE / ORALABRLD, RS2010-10-19a50c72e98297…
2026-08-01 22:54:322026-06N022512-003PRADAXAEQ 110MG BASECAPSULE / ORALABRLD2015-11-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N022512-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N022512-002AB1a50c72e98297…
2026-08-01 22:54:322026-06N022512-003AB1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N022512-00179322732025-09-07Drug substance, Drug product2011-08-01a50c72e98297…
2026-08-01 22:54:322026-06N022512-0017932273*PED2026-03-07Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022512-00190348222031-01-20U-17592015-11-09a50c72e98297…
2026-08-01 22:54:322026-06N022512-0019034822*PED2031-07-20Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022512-00279322732025-09-07Drug substance, Drug producta50c72e98297…
2026-08-01 22:54:322026-06N022512-0027932273*PED2026-03-07Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022512-00290348222031-01-20U-17592015-11-09a50c72e98297…
2026-08-01 22:54:322026-06N022512-0029034822*PED2031-07-20Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022512-00379322732025-09-07Drug substance, Drug product2015-12-15a50c72e98297…
2026-08-01 22:54:322026-06N022512-0037932273*PED2026-03-07Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022512-00390348222031-01-20U-17592015-12-15a50c72e98297…
2026-08-01 22:54:322026-06N022512-0039034822*PED2031-07-20Pediatric 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 ETEXILATE MESYLATEBoehringer Ingelheim Pharmaceuticals Inc.ba74e3cd-b06f-4145-b284-5fd6b84ff3c92025-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022512
application number: NDA022512
ndc (product): 0597-0360

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DABIGATRAN ETEXILATE MESYLATE150 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1037045Internal RxNorm lookup
1037049Internal RxNorm lookup
1037179Internal RxNorm lookup
1037181Internal RxNorm lookup
1723476Internal RxNorm lookup
1723478Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ba74e3cd-b06f-4145-b284-5fd6b84ff3c9Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0597-0360-42Pradaxa1 in 1 BLISTER PACKCAPSULE148
0597-0360-42Pradaxa12 in 1 CARTONCAPSULE1248
0597-0360-55Pradaxa1 in 1 CARTONCAPSULE148
0597-0360-55Pradaxa60 in 1 BOTTLECAPSULE6048
0597-0360-82Pradaxa60 in 1 CARTONCAPSULE6048
0597-0360-82Pradaxa1 in 1 BLISTER PACKCAPSULE148

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0360-55EA - Each0597-036001b0298a-89e0-483d-a938-b23342f7ee3112018-02-20
0597-0360-82EA - Each0597-0360a20c19a8-bb2c-4e2c-bb71-a1a2e0d5933f12018-01-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DABIGATRAN ETEXILATE MESYLATEACTIVE INGREDIENTSC7NUW5IITPRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]33
DABIGATRANACTIVE MOIETYI0VM4M70GCPRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0360PRADAXA (DABIGATRAN ETEXILATE MESYLATE) CAPSULE [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]47Current NDC, Legacy NDC, 6 package rows20231201_ba74e3cd-b06f-4145-b284-5fd6b84ff3c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723476dabigatran etexilate 110 MG Oral CapsulePSNba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1037045dabigatran etexilate 150 MG Oral CapsulePSNba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1037179dabigatran etexilate 75 MG Oral CapsulePSNba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1723478Pradaxa 110 MG Oral CapsulePSNba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1037049Pradaxa 150 MG Oral CapsulePSNba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1037181Pradaxa 75 MG Oral CapsulePSNba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1723478dabigatran etexilate 110 MG Oral Capsule [Pradaxa]SBDba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1037049dabigatran etexilate 150 MG Oral Capsule [Pradaxa]SBDba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1037181dabigatran etexilate 75 MG Oral Capsule [Pradaxa]SBDba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1723476dabigatran etexilate 110 MG Oral CapsuleSCDba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1037045dabigatran etexilate 150 MG Oral CapsuleSCDba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1037179dabigatran etexilate 75 MG Oral CapsuleSCDba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1723476dabigatran etexilate 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral CapsuleSYba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1037045dabigatran etexilate 150 MG (dabigatran etexilate mesylate 172.95 MG) Oral CapsuleSYba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1037179dabigatran etexilate 75 MG (as dabigatran etexilate mesylate 86.48 MG) Oral CapsuleSYba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1723478Pradaxa 110 MG (as dabigatran etexilate mesylate 126.83 MG) Oral CapsuleSYba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1723478Pradaxa 110 MG Oral CapsuleSYba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1037049Pradaxa 150 MG (as dabigatran etexilate mesylate 172.95 MG) Oral CapsuleSYba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1037049Pradaxa 150 MG Oral CapsuleSYba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1037181Pradaxa 75 MG (as dabigatran etexilate mesylate 86.48 MG) Oral CapsuleSYba74e3cd-b06f-4145-b284-5fd6b84ff3c948
1037181Pradaxa 75 MG Oral CapsuleSYba74e3cd-b06f-4145-b284-5fd6b84ff3c948
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
0597-0360-420059703604212 BLISTER PACK in 1 CARTON (0597-0360-42) > 1 CAPSULE in 1 BLISTER PACK12 blister pack2017-07-280000-00-00NoNoCurrent
0597-0360-55005970360551 BOTTLE in 1 CARTON (0597-0360-55) / 60 CAPSULE in 1 BOTTLE1 bottle2017-07-280000-00-00NoNoCurrent
0597-0360-820059703608260 BLISTER PACK in 1 CARTON (0597-0360-82) / 1 CAPSULE in 1 BLISTER PACK60 blister pack2017-07-280000-00-00NoNoCurrent