pradaxa

Generic: dabigatran etexilate mesylate

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

Drug Facts

Product Profile

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

dabigatran etexilate mesylate 110 mg/1

Manufacturer
Boehringer Ingelheim Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0597-0108
Product ID 0597-0108_ecf1aa06-c610-4fdb-a380-2e716d7e63c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022512
Listing Expiration 2026-12-31
Marketing Start 2015-11-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05970108
Hyphenated Format 0597-0108

Supplemental Identifiers

RxCUI
1037045 1037049 1037179 1037181 1723476 1723478
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 mesylate (source: ndc)
Application Number NDA022512 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 110 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0597-0108-54) / 60 CAPSULE in 1 BOTTLE
  • 10 BLISTER PACK in 1 CARTON (0597-0108-60) / 6 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (2)

0597-0108-54 1 BOTTLE in 1 CARTON (0597-0108-54) / 60 CAPSULE in 1 BOTTLE 0597-0108-60 10 BLISTER PACK in 1 CARTON (0597-0108-60) / 6 CAPSULE in 1 BLISTER PACK

Ingredients (1)

dabigatran etexilate mesylate (110 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": "ecf1aa06-c610-4fdb-a380-2e716d7e63c2", "openfda": {"unii": ["SC7NUW5IIT"], "rxcui": ["1037045", "1037049", "1037179", "1037181", "1723476", "1723478"], "spl_set_id": ["ba74e3cd-b06f-4145-b284-5fd6b84ff3c9"], "manufacturer_name": ["Boehringer Ingelheim Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0597-0108-54)  / 60 CAPSULE in 1 BOTTLE", "package_ndc": "0597-0108-54", "marketing_start_date": "20170707"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (0597-0108-60)  / 6 CAPSULE in 1 BLISTER PACK", "package_ndc": "0597-0108-60", "marketing_start_date": "20151123"}], "brand_name": "Pradaxa", "product_id": "0597-0108_ecf1aa06-c610-4fdb-a380-2e716d7e63c2", "dosage_form": "CAPSULE", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "0597-0108", "generic_name": "dabigatran etexilate mesylate", "labeler_name": "Boehringer Ingelheim Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pradaxa", "active_ingredients": [{"name": "DABIGATRAN ETEXILATE MESYLATE", "strength": "110 mg/1"}], "application_number": "NDA022512", "marketing_category": "NDA", "marketing_start_date": "20151123", "listing_expiration_date": "20261231"}