Package 68083-461-10
Brand: fosphenytoin sodium
Generic: fosphenytoin sodiumPackage Facts
Identity
Package NDC
68083-461-10
Digits Only
6808346110
Product NDC
68083-461
Description
10 VIAL, SINGLE-DOSE in 1 CARTON (68083-461-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-461-01)
Marketing
Marketing Status
Brand
fosphenytoin sodium
Generic
fosphenytoin sodium
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "00f57b3c-3819-440e-a928-eeec0fee27aa", "openfda": {"upc": ["0368083461010", "0368083461102", "0368083460259"], "unii": ["7VLR55452Z"], "rxcui": ["1670195", "1670200"], "spl_set_id": ["49b08648-6a83-42c7-ae7b-80c29f2534fc"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (68083-461-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-461-01)", "package_ndc": "68083-461-10", "marketing_start_date": "20231013"}], "brand_name": "Fosphenytoin sodium", "product_id": "68083-461_00f57b3c-3819-440e-a928-eeec0fee27aa", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Cytochrome P450 1A2 Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C19 Inducers [MoA]", "Cytochrome P450 2C8 Inducers [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 2D6 Inducers [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68083-461", "generic_name": "Fosphenytoin sodium", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fosphenytoin sodium", "active_ingredients": [{"name": "FOSPHENYTOIN SODIUM", "strength": "50 mg/mL"}], "application_number": "ANDA214926", "marketing_category": "ANDA", "marketing_start_date": "20231013", "listing_expiration_date": "20261231"}