NDC 0378-3750

Phenytek

Phenytoin Sodium

Phenytek is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Phenytoin Sodium.

• Product ID: 0378-3750_1d5e0f86-680d-4351-9606-da6573e8c500
• NDC: 0378-3750
• Product Type: Human Prescription Drug
• Proprietary Name: Phenytek
• Generic Name: Phenytoin Sodium
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2001-12-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040298
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: PHENYTOIN SODIUM
• Active Ingredient Strength: 300 mg/1
• 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: 2020-12-31

Packaging

NDC 0378-3750-01

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-01)

• Marketing Start Date: 2001-12-10
• Marketing End Date: 2030-01-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-3750-01 [00378375001]

Phenytek CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA040298
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2001-12-10

NDC 0378-3750-93 [00378375093]

Phenytek CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA040298
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2001-12-10

Drug Details

Active Ingredients

Ingredient	Strength
PHENYTOIN SODIUM	300 mg/1

OpenFDA Data

• SPL SET ID: 0f94c791-8b07-4b41-927e-c9f28bec5f60
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 4182431BJH
• RxNorm Concept Unique ID - RxCUI:
  • 855863
  • 855873
  • 855861
  • 855875

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]
• 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 "Phenytek" or generic name "Phenytoin Sodium"

NDC	Brand Name	Generic Name
0378-2670	Phenytek	extended phenytoin sodium
0378-3750	Phenytek	phenytoin sodium
0071-0369	Dilantin	Phenytoin Sodium
0071-3740	Dilantin	Phenytoin Sodium
0904-6187	Extended Phenytoin Sodium	Phenytoin Sodium
10135-603	Extended Phenytoin Sodium	Phenytoin Sodium
42291-772	Extended Phenytoin Sodium	Phenytoin Sodium
0378-1560	Phenytoin Sodium	phenytoin sodium
0404-9932	Phenytoin Sodium	Phenytoin Sodium
0404-9933	Phenytoin Sodium	Phenytoin Sodium
0615-1343	Phenytoin Sodium	phenytoin sodium
0615-8020	Phenytoin Sodium	Phenytoin Sodium
0641-0493	Phenytoin Sodium	Phenytoin Sodium
0641-2555	Phenytoin Sodium	Phenytoin Sodium
0641-6138	Phenytoin Sodium	Phenytoin Sodium
0641-6139	Phenytoin Sodium	Phenytoin Sodium
21695-167	Phenytoin Sodium	Phenytoin Sodium
29300-379	Phenytoin Sodium	Phenytoin Sodium
39822-4050	PHENYTOIN SODIUM	PHENYTOIN SODIUM
42192-614	PHENYTOIN SODIUM	PHENYTOIN SODIUM