NDC 50090-2903

PHENYTOIN SODIUM

Phenytoin Sodium

PHENYTOIN SODIUM 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 ID50090-2903_5e4e29a9-3492-4630-9754-1b4a4e670271
NDC50090-2903
Product TypeHuman Prescription Drug
Proprietary NamePHENYTOIN SODIUM
Generic NamePhenytoin Sodium
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2006-12-12
Marketing CategoryANDA / ANDA
Application NumberANDA040621
Labeler NameA-S Medication Solutions
Substance NamePHENYTOIN SODIUM
Active Ingredient Strength100 mg/1
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 FlagE
Listing Certified Through2018-12-31

Packaging

NDC SPL Data Element Entries

NDC 50090-2903-0 [50090290300]

PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA040621
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-06
Marketing End Date2017-09-30
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN SODIUM100 mg/1

OpenFDA Data

SPL SET ID:0bff6a19-3848-48cc-9ad9-cd6ad4501a2b
Manufacturer
UNII

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 "PHENYTOIN SODIUM" or generic name "Phenytoin Sodium"

NDCBrand NameGeneric Name
0378-1560Phenytoin Sodiumphenytoin sodium
0404-9932Phenytoin SodiumPhenytoin Sodium
0404-9933Phenytoin SodiumPhenytoin Sodium
0615-1343Phenytoin Sodiumphenytoin sodium
0615-8020Phenytoin SodiumPhenytoin Sodium
0641-0493Phenytoin SodiumPhenytoin Sodium
0641-2555Phenytoin SodiumPhenytoin Sodium
0641-6138Phenytoin SodiumPhenytoin Sodium
0641-6139Phenytoin SodiumPhenytoin Sodium
21695-167Phenytoin SodiumPhenytoin Sodium
29300-379Phenytoin SodiumPhenytoin Sodium
39822-4050PHENYTOIN SODIUMPHENYTOIN SODIUM
42192-614PHENYTOIN SODIUMPHENYTOIN SODIUM
70518-0107Phenytoin SodiumPhenytoin Sodium
70518-0981PHENYTOIN SODIUMPHENYTOIN SODIUM
70518-1776Phenytoin SodiumPhenytoin Sodium
71335-0913Phenytoin SodiumPhenytoin Sodium
71335-0232PHENYTOIN SODIUMPHENYTOIN SODIUM
50090-3499Phenytoin SodiumPhenytoin Sodium
50090-2903PHENYTOIN SODIUMPHENYTOIN SODIUM
50090-3539Phenytoin SodiumPhenytoin Sodium
51079-905Phenytoin SodiumPhenytoin Sodium
51662-1251PHENYTOIN SODIUMPHENYTOIN SODIUM
51662-1250PHENYTOIN SODIUMPHENYTOIN SODIUM
51672-4111Phenytoin SodiumPhenytoin Sodium
52584-555Phenytoin SodiumPhenytoin Sodium
52584-493Phenytoin SodiumPhenytoin Sodium
53002-1501PHENYTOIN SODIUMPHENYTOIN SODIUM
53808-0652Phenytoin SodiumPhenytoin Sodium
55154-5496Phenytoin SodiumPhenytoin Sodium
55154-5117Phenytoin SodiumPhenytoin Sodium
57664-808Phenytoin SodiumPhenytoin Sodium
58118-1402PHENYTOIN SODIUMPHENYTOIN SODIUM
58118-4111Phenytoin SodiumPhenytoin Sodium
61919-815PHENYTOIN SODIUMPHENYTOIN SODIUM
62756-299phenytoin sodiumphenytoin sodium
62756-402PHENYTOIN SODIUMPHENYTOIN SODIUM
62756-432phenytoin sodiumphenytoin sodium
63187-891PHENYTOIN SODIUMPHENYTOIN SODIUM
63629-6382PHENYTOIN SODIUMPHENYTOIN SODIUM
63629-6364PHENYTOIN SODIUMPHENYTOIN SODIUM
63629-2552Phenytoin SodiumPhenytoin Sodium
64725-4111Phenytoin SodiumPhenytoin Sodium
67046-585Phenytoin SodiumPhenytoin Sodium
67296-1251PHENYTOIN SODIUMPHENYTOIN SODIUM
67544-517Phenytoin SodiumPhenytoin Sodium
0071-0369DilantinPhenytoin Sodium
0071-3740DilantinPhenytoin Sodium
43353-131DilantinPhenytoin Sodium
0904-6187Extended Phenytoin SodiumPhenytoin Sodium

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