Package 0597-0355-09

Brand: pradaxa

Generic: dabigatran etexilate mesylate
NDC Package

Package Facts

Identity

Package NDC 0597-0355-09
Digits Only 0597035509
Product NDC 0597-0355
Product ID 0597-0355_ecf1aa06-c610-4fdb-a380-2e716d7e63c2
Description

1 BOTTLE in 1 CARTON (0597-0355-09) / 60 CAPSULE in 1 BOTTLE

Marketing

Marketing Status
Marketed Since 2017-07-28
Brand pradaxa
Generic dabigatran etexilate mesylate
Sample Package No

Linked Drug Pages (1)

Pradaxa ndc-match (0.95)

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 (0597-0355-09)  / 60 CAPSULE in 1 BOTTLE", "package_ndc": "0597-0355-09", "marketing_start_date": "20170728"}, {"sample": false, "description": "60 BLISTER PACK in 1 CARTON (0597-0355-56)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0597-0355-56", "marketing_start_date": "20170728"}], "brand_name": "Pradaxa", "product_id": "0597-0355_ecf1aa06-c610-4fdb-a380-2e716d7e63c2", "dosage_form": "CAPSULE", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "0597-0355", "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": "75 mg/1"}], "application_number": "NDA022512", "marketing_category": "NDA", "marketing_start_date": "20110808", "listing_expiration_date": "20261231"}