Package 68727-800-01
Brand: defitelio
Generic: defibrotide sodiumPackage Facts
Identity
Package NDC
68727-800-01
Digits Only
6872780001
Product NDC
68727-800
Description
2.5 mL in 1 VIAL (68727-800-01)
Marketing
Marketing Status
Brand
defitelio
Generic
defibrotide sodium
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "0269ad44-e351-4411-8866-d8d53e28fb74", "openfda": {"unii": ["L7CHH2B2J0"], "rxcui": ["1746527", "1746532"], "spl_set_id": ["2c3db989-d7ad-41ed-9ebf-698dcf6c24ec"], "manufacturer_name": ["Jazz Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2.5 mL in 1 VIAL (68727-800-01)", "package_ndc": "68727-800-01", "marketing_start_date": "20160330"}, {"sample": false, "description": "25 mL in 1 CARTON (68727-800-02)", "package_ndc": "68727-800-02", "marketing_start_date": "20160330"}], "brand_name": "DEFITELIO", "product_id": "68727-800_0269ad44-e351-4411-8866-d8d53e28fb74", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "68727-800", "generic_name": "defibrotide sodium", "labeler_name": "Jazz Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEFITELIO", "active_ingredients": [{"name": "DEFIBROTIDE SODIUM", "strength": "80 mg/mL"}], "application_number": "NDA208114", "marketing_category": "NDA", "marketing_start_date": "20160330", "listing_expiration_date": "20261231"}