NDC 67457-516

Fosphenytoin Sodium

Fosphenytoin Sodium

Fosphenytoin Sodium is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Fosphenytoin Sodium.

• Product ID: 67457-516_6c9313b1-9247-4c40-b6aa-1ba1554b6c7d
• NDC: 67457-516
• Product Type: Human Prescription Drug
• Proprietary Name: Fosphenytoin Sodium
• Generic Name: Fosphenytoin Sodium
• Dosage Form: Injection, Solution
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2016-12-06
• Marketing End Date: 2022-12-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078736
• Labeler Name: Mylan Institutional LLC
• Substance Name: FOSPHENYTOIN SODIUM
• Active Ingredient Strength: 50 mg/mL
• Pharm Classes: 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]
• NDC Exclude Flag: N

Packaging

NDC 67457-516-25

25 VIAL, SINGLE-DOSE in 1 CARTON (67457-516-25) > 2 mL in 1 VIAL, SINGLE-DOSE (67457-516-00)

• Marketing Start Date: 2016-12-06
• Marketing End Date: 2022-12-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-516-00 [67457051600]

Fosphenytoin Sodium INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078736
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-12-06

NDC 67457-516-25 [67457051625]

Fosphenytoin Sodium INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078736
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-12-06

Drug Details

Active Ingredients

Ingredient	Strength
FOSPHENYTOIN SODIUM	50 mg/mL

OpenFDA Data

• SPL SET ID: 564feac7-eb0d-42a0-a0f1-9613deeb0cec
• Manufacturer:
  • Mylan Institutional LLC
• UNII:
  • 7VLR55452Z
• RxNorm Concept Unique ID - RxCUI:
  • 1670195
  • 1670200

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 "Fosphenytoin Sodium" or generic name "Fosphenytoin Sodium"

NDC	Brand Name	Generic Name
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
70121-1381	Fosphenytoin Sodium	Fosphenytoin Sodium
70121-1390	Fosphenytoin Sodium	Fosphenytoin Sodium
65162-999	Fosphenytoin Sodium	Fosphenytoin Sodium
67457-517	Fosphenytoin Sodium	Fosphenytoin Sodium
67457-516	Fosphenytoin Sodium	Fosphenytoin Sodium
0069-5471	CEREBYX	Fosphenytoin Sodium
0069-5474	CEREBYX	Fosphenytoin Sodium
0069-6001	CEREBYX	Fosphenytoin Sodium
63323-403	Fosphenytoin	FOSPHENYTOIN SODIUM