Package 0069-5474-02
Brand: cerebyx
Generic: fosphenytoin sodiumPackage Facts
Identity
Package NDC
0069-5474-02
Digits Only
0069547402
Product NDC
0069-5474
Description
10 VIAL, SINGLE-DOSE in 1 PACKAGE (0069-5474-02) / 10 mL in 1 VIAL, SINGLE-DOSE (0069-5474-01)
Marketing
Marketing Status
Brand
cerebyx
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": "fcfe3e97-071d-44d8-8235-bb6b67567c18", "openfda": {"unii": ["7VLR55452Z"], "rxcui": ["1670195", "1670197", "1670200", "1670201"], "spl_set_id": ["de5a6711-4abb-4c3d-a18b-266b094ace11"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 PACKAGE (0069-5474-02) / 10 mL in 1 VIAL, SINGLE-DOSE (0069-5474-01)", "package_ndc": "0069-5474-02", "marketing_start_date": "20131028"}], "brand_name": "CEREBYX", "product_id": "0069-5474_fcfe3e97-071d-44d8-8235-bb6b67567c18", "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": "0069-5474", "generic_name": "Fosphenytoin Sodium", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CEREBYX", "active_ingredients": [{"name": "FOSPHENYTOIN SODIUM", "strength": "50 mg/mL"}], "application_number": "NDA020450", "marketing_category": "NDA", "marketing_start_date": "20131028", "listing_expiration_date": "20261231"}