Package 0597-0445-87
Brand: pradaxa
Generic: dabigatran etexilatePackage Facts
Identity
Package NDC
0597-0445-87
Digits Only
0597044587
Product NDC
0597-0445
Description
1 BAG in 1 CARTON (0597-0445-87) / 60 PELLET in 1 BAG
Marketing
Marketing Status
Brand
pradaxa
Generic
dabigatran etexilate
Sample Package
No
Linked Drug Pages (1)
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 (0597-0445-87) / 60 PELLET in 1 BAG", "package_ndc": "0597-0445-87", "marketing_start_date": "20220316"}], "brand_name": "Pradaxa", "product_id": "0597-0445_56b1a7c2-0afd-40c6-bda5-563e234a9f28", "dosage_form": "PELLET", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "0597-0445", "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": "110 mg/1"}], "application_number": "NDA214358", "marketing_category": "NDA", "marketing_start_date": "20220316", "listing_expiration_date": "20261231"}