Package 65219-646-05
Brand: protamine sulfate
Generic: protamine sulfatePackage Facts
Identity
Package NDC
65219-646-05
Digits Only
6521964605
Product NDC
65219-646
Description
25 VIAL, SINGLE-DOSE in 1 TRAY (65219-646-05) / 5 mL in 1 VIAL, SINGLE-DOSE (65219-646-02)
Marketing
Marketing Status
Brand
protamine sulfate
Generic
protamine sulfate
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "c76876da-b9a8-45d0-9278-7df3288d3a06", "openfda": {"upc": ["0365219646020"], "unii": ["0DE9724IHC"], "rxcui": ["1796672"], "spl_set_id": ["c76876da-b9a8-45d0-9278-7df3288d3a06"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (65219-646-05) / 5 mL in 1 VIAL, SINGLE-DOSE (65219-646-02)", "package_ndc": "65219-646-05", "marketing_start_date": "20250328"}], "brand_name": "Protamine Sulfate", "product_id": "65219-646_c76876da-b9a8-45d0-9278-7df3288d3a06", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Heparin Binding Activity [MoA]", "Heparin Reversal Agent [EPC]", "Reversed Anticoagulation Activity [PE]"], "product_ndc": "65219-646", "generic_name": "PROTAMINE SULFATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Protamine Sulfate", "active_ingredients": [{"name": "PROTAMINE SULFATE", "strength": "10 mg/mL"}], "application_number": "ANDA089454", "marketing_category": "ANDA", "marketing_start_date": "20250328", "listing_expiration_date": "20261231"}