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

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 Identifiers#

Field, Values table
FieldValues
UniiSC7NUW5IIT
Rxcui2590616, 2590619, 2590620, 2590621, 2590623, 2590625, 2590627, 2590629, 2590631, 2590633, 2590635, 2590637

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