NDC 0069-5474

CEREBYX

Fosphenytoin Sodium

CEREBYX is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Fosphenytoin Sodium.

Product ID0069-5474_3b3e1060-49e9-42c3-a6f9-76ba0750b504
NDC0069-5474
Product TypeHuman Prescription Drug
Proprietary NameCEREBYX
Generic NameFosphenytoin Sodium
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2013-10-28
Marketing CategoryNDA / NDA
Application NumberNDA020450
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameFOSPHENYTOIN SODIUM
Active Ingredient Strength50 mg/mL
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0069-5474-02

10 VIAL in 1 PACKAGE (0069-5474-02) > 10 mL in 1 VIAL (0069-5474-01)
Marketing Start Date2013-10-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-5474-02 [00069547402]

CEREBYX INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020450
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-10-28

NDC 0069-5474-01 [00069547401]

CEREBYX INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020450
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2013-10-28

Drug Details

Active Ingredients

IngredientStrength
FOSPHENYTOIN SODIUM50 mg/mL

OpenFDA Data

SPL SET ID:de5a6711-4abb-4c3d-a18b-266b094ace11
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1670201
  • 1670195
  • 1670200
  • 1670197
  • Pharmacological Class

    • Anti-epileptic Agent [EPC]
    • Decreased Central Nervous System Disorganized Electrical Activity [PE]
    • Cytochrome P450 1A2 Inducers [MoA]
    • Cytochrome P450 2B6 Inducers [MoA]
    • Cytochrome P450 2C8 Inducers [MoA]
    • Cytochrome P450 2C19 Inducers [MoA]
    • Cytochrome P450 2D6 Inducers [MoA]
    • Cytochrome P450 3A Inducers [MoA]
    • Cytochrome P450 2C9 Inducers [MoA]

    NDC Crossover Matching brand name "CEREBYX" or generic name "Fosphenytoin Sodium"

    NDCBrand NameGeneric Name
    0069-5471CEREBYXFosphenytoin Sodium
    0069-5474CEREBYXFosphenytoin Sodium
    0069-6001CEREBYXFosphenytoin Sodium
    63323-403FosphenytoinFOSPHENYTOIN SODIUM
    0143-9782Fosphenytoin SodiumFosphenytoin Sodium
    0143-9788Fosphenytoin SodiumFosphenytoin Sodium
    0641-6136Fosphenytoin SodiumFosphenytoin Sodium
    0641-6137Fosphenytoin SodiumFosphenytoin Sodium
    64679-729FOSPHENYTOIN SODIUMfosphenytoin sodium
    64679-730FOSPHENYTOIN SODIUMfosphenytoin sodium
    65162-998Fosphenytoin SodiumFosphenytoin Sodium

    Trademark Results [CEREBYX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CEREBYX
    CEREBYX
    75047723 2135222 Live/Registered
    WARNER-LAMBERT COMPANY LLC
    1996-01-19
    CEREBYX
    CEREBYX
    73800267 1578580 Dead/Cancelled
    WARNER-LAMBERT COMPANY
    1989-05-15

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.