pradaxa

Generic: dabigatran etexilate

Labeler: boehringer ingelheim pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pradaxa
Generic Name dabigatran etexilate
Labeler boehringer ingelheim pharmaceuticals, inc.
Dosage Form PELLET
Routes
ORAL
Active Ingredients

dabigatran etexilate mesylate 40 mg/1

Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0597-0435
Product ID 0597-0435_56b1a7c2-0afd-40c6-bda5-563e234a9f28
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214358
Listing Expiration 2026-12-31
Marketing Start 2022-03-16

Pharmacologic Class

Classes
direct thrombin inhibitor [epc] thrombin inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05970435
Hyphenated Format 0597-0435

Supplemental Identifiers

RxCUI
2590616 2590619 2590620 2590621 2590623 2590625 2590627 2590629 2590631 2590633 2590635 2590637
UNII
SC7NUW5IIT

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pradaxa (source: ndc)
Generic Name dabigatran etexilate (source: ndc)
Application Number NDA214358 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 1 BAG in 1 CARTON (0597-0435-96) / 60 PELLET in 1 BAG
source: ndc

Packages (1)

0597-0435-96 1 BAG in 1 CARTON (0597-0435-96) / 60 PELLET in 1 BAG

Ingredients (1)

dabigatran etexilate mesylate (40 mg/1)

Linked Drug Pages (1)

Pradaxa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "56b1a7c2-0afd-40c6-bda5-563e234a9f28", "openfda": {"unii": ["SC7NUW5IIT"], "rxcui": ["2590616", "2590619", "2590620", "2590621", "2590623", "2590625", "2590627", "2590629", "2590631", "2590633", "2590635", "2590637"], "spl_set_id": ["9ac0a64a-8666-45f7-9d4f-40fd894f7e6d"], "manufacturer_name": ["Boehringer Ingelheim Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 CARTON (0597-0435-96)  / 60 PELLET in 1 BAG", "package_ndc": "0597-0435-96", "marketing_start_date": "20220316"}], "brand_name": "Pradaxa", "product_id": "0597-0435_56b1a7c2-0afd-40c6-bda5-563e234a9f28", "dosage_form": "PELLET", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "0597-0435", "generic_name": "dabigatran etexilate", "labeler_name": "Boehringer Ingelheim Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pradaxa", "active_ingredients": [{"name": "DABIGATRAN ETEXILATE MESYLATE", "strength": "40 mg/1"}], "application_number": "NDA214358", "marketing_category": "NDA", "marketing_start_date": "20220316", "listing_expiration_date": "20261231"}