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 ID: 0069-5474_3b3e1060-49e9-42c3-a6f9-76ba0750b504
• NDC: 0069-5474
• Product Type: Human Prescription Drug
• Proprietary Name: CEREBYX
• Generic Name: Fosphenytoin Sodium
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2013-10-28
• Marketing Category: NDA / NDA
• Application Number: NDA020450
• Labeler Name: Pfizer Laboratories Div Pfizer Inc
• Substance Name: FOSPHENYTOIN SODIUM
• Active Ingredient Strength: 50 mg/mL
• Pharm Classes: 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 Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0069-5474-02

10 VIAL in 1 PACKAGE (0069-5474-02) > 10 mL in 1 VIAL (0069-5474-01)

• Marketing Start Date: 2013-10-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-5474-02 [00069547402]

CEREBYX INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA020450
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-10-28

NDC 0069-5474-01 [00069547401]

CEREBYX INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA020450
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-10-28

Drug Details

Active Ingredients

Ingredient	Strength
FOSPHENYTOIN SODIUM	50 mg/mL

OpenFDA Data

• SPL SET ID: de5a6711-4abb-4c3d-a18b-266b094ace11
• Manufacturer:
  • Pfizer Laboratories Div Pfizer Inc
• UNII:
  • 7VLR55452Z
• 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"

NDC	Brand Name	Generic Name
0069-5471	CEREBYX	Fosphenytoin Sodium
0069-5474	CEREBYX	Fosphenytoin Sodium
0069-6001	CEREBYX	Fosphenytoin Sodium
63323-403	Fosphenytoin	FOSPHENYTOIN SODIUM
0143-9782	Fosphenytoin Sodium	Fosphenytoin Sodium
0143-9788	Fosphenytoin Sodium	Fosphenytoin Sodium
0641-6136	Fosphenytoin Sodium	Fosphenytoin Sodium
0641-6137	Fosphenytoin Sodium	Fosphenytoin Sodium
64679-729	FOSPHENYTOIN SODIUM	fosphenytoin sodium
64679-730	FOSPHENYTOIN SODIUM	fosphenytoin sodium
65162-998	Fosphenytoin Sodium	Fosphenytoin Sodium