Package 0378-0265-91
Brand: dabigatran etexilate
Generic: dabigatran etexilatePackage Facts
Identity
Package NDC
0378-0265-91
Digits Only
0378026591
Product NDC
0378-0265
Description
60 CAPSULE in 1 BOTTLE, PLASTIC (0378-0265-91)
Marketing
Marketing Status
Brand
dabigatran etexilate
Generic
dabigatran etexilate
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "6c6b985e-111f-4fe9-a1ca-785c450e444b", "openfda": {"upc": ["0303780266933"], "unii": ["SC7NUW5IIT"], "rxcui": ["1037045", "1037179"], "spl_set_id": ["baafb5be-ffe6-4755-a7ab-817b3c9b222d"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (0378-0265-91)", "package_ndc": "0378-0265-91", "marketing_start_date": "20250225"}], "brand_name": "Dabigatran Etexilate", "product_id": "0378-0265_6c6b985e-111f-4fe9-a1ca-785c450e444b", "dosage_form": "CAPSULE", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "0378-0265", "generic_name": "Dabigatran Etexilate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dabigatran Etexilate", "active_ingredients": [{"name": "DABIGATRAN ETEXILATE MESYLATE", "strength": "75 mg/1"}], "application_number": "ANDA208067", "marketing_category": "ANDA", "marketing_start_date": "20250225", "listing_expiration_date": "20261231"}