Package 0597-0440-53

Brand: pradaxa

Generic: dabigatran etexilate
NDC Package

Package Facts

Identity

Package NDC 0597-0440-53
Digits Only 0597044053
Product NDC 0597-0440
Product ID 0597-0440_56b1a7c2-0afd-40c6-bda5-563e234a9f28
Description

1 BAG in 1 CARTON (0597-0440-53) / 60 PELLET in 1 BAG

Marketing

Marketing Status
Marketed Since 2022-03-16
Brand pradaxa
Generic dabigatran etexilate
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": "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 (0597-0440-53)  / 60 PELLET in 1 BAG", "package_ndc": "0597-0440-53", "marketing_start_date": "20220316"}], "brand_name": "Pradaxa", "product_id": "0597-0440_56b1a7c2-0afd-40c6-bda5-563e234a9f28", "dosage_form": "PELLET", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "0597-0440", "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": "50 mg/1"}], "application_number": "NDA214358", "marketing_category": "NDA", "marketing_start_date": "20220316", "listing_expiration_date": "20261231"}