NDC 50090-0029

Dilantin

Phenytoin Sodium

Dilantin is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Phenytoin Sodium.

• Product ID: 50090-0029_8657e0f0-e112-44ad-a896-c3ce1b884012
• NDC: 50090-0029
• Product Type: Human Prescription Drug
• Proprietary Name: Dilantin
• Generic Name: Phenytoin Sodium
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 1976-08-27
• Marketing Category: ANDA / ANDA
• Application Number: ANDA084349
• Labeler Name: A-S Medication Solutions
• Substance Name: PHENYTOIN SODIUM
• Active Ingredient Strength: 100 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 50090-0029-2

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-0029-2)

• Marketing Start Date: 2014-11-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-0029-2 [50090002902]

Dilantin CAPSULE, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA084349
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-11-28

Drug Details

Active Ingredients

Ingredient	Strength
PHENYTOIN SODIUM	100 mg/1

OpenFDA Data

• SPL SET ID: f5b7e576-49b1-4633-ab0a-6ab94922e970
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • 4182431BJH
• RxNorm Concept Unique ID - RxCUI:
  • 855673
  • 855671

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 "Dilantin" or generic name "Phenytoin Sodium"

NDC	Brand Name	Generic Name
0071-0369	Dilantin	Extended Phenytoin Sodium
0071-3740	Dilantin	Extended Phenytoin Sodium
68151-1019	Dilantin	Dilantin
69189-3742	Dilantin	Dilantin
70518-0980	Dilantin	Dilantin
43353-131	Dilantin	Dilantin
50090-0029	Dilantin	Dilantin
0904-6187	Extended Phenytoin Sodium	Phenytoin Sodium
10135-603	Extended Phenytoin Sodium	Phenytoin Sodium
0378-3750	Phenytek	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