FDA.reportPublic FDA data

Pradaxa

Product NDC
0597-0355
11-digit product format
005970355
Labeler code
0597
Product ID
0597-0355_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
2011-08-08
Substance
DABIGATRAN ETEXILATE MESYLATE
Active strength
75 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DABIGATRAN ETEXILATE MESYLATE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSC7NUW5IIT
Rxcui1037045, 1037049, 1037179, 1037181, 1723476, 1723478

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
0597-0355-09Pradaxa1 in 1 CARTONCAPSULE148
0597-0355-09Pradaxa60 in 1 BOTTLECAPSULE6048
0597-0355-53Pradaxa1 in 1 BLISTER PACKCAPSULE148
0597-0355-53Pradaxa12 in 1 CARTONCAPSULE1248
0597-0355-56Pradaxa60 in 1 CARTONCAPSULE6048
0597-0355-56Pradaxa1 in 1 BLISTER PACKCAPSULE148

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0355-09EA - Each0597-0355ca721a5e-583c-4b4b-b7f9-7c95ca47a08412018-02-20
0597-0355-56EA - Each0597-035541ff2143-5ab3-4210-822b-b6ed7c8b7f1012018-02-20

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
0597-0355PRADAXA (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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0355-09005970355091 BOTTLE in 1 CARTON (0597-0355-09) / 60 CAPSULE in 1 BOTTLE1 bottle2017-07-280000-00-00NoNoCurrent
0597-0355-530059703555312 BLISTER PACK in 1 CARTON (0597-0355-53) > 1 CAPSULE in 1 BLISTER PACK12 blister pack2017-07-280000-00-00NoNoCurrent
0597-0355-560059703555660 BLISTER PACK in 1 CARTON (0597-0355-56) / 1 CAPSULE in 1 BLISTER PACK60 blister pack2017-07-280000-00-00NoNoCurrent