NDC 71335-1349

Extended Phenytoin Sodium

Phenytoin Sodium

Extended Phenytoin Sodium is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Phenytoin Sodium.

Product ID71335-1349_022272a9-f9a5-426f-a58a-4b479ca36df0
NDC71335-1349
Product TypeHuman Prescription Drug
Proprietary NameExtended Phenytoin Sodium
Generic NamePhenytoin Sodium
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-06-10
Marketing CategoryANDA / ANDA
Application NumberANDA204309
Labeler NameBryant Ranch Prepack
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 FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71335-1349-1

100 CAPSULE in 1 BOTTLE (71335-1349-1)
Marketing Start Date2019-09-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1349-6 [71335134906]

Extended Phenytoin Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA204309
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-26

NDC 71335-1349-2 [71335134902]

Extended Phenytoin Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA204309
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-26

NDC 71335-1349-4 [71335134904]

Extended Phenytoin Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA204309
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-26

NDC 71335-1349-5 [71335134905]

Extended Phenytoin Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA204309
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-26

NDC 71335-1349-3 [71335134903]

Extended Phenytoin Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA204309
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-26

NDC 71335-1349-1 [71335134901]

Extended Phenytoin Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA204309
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-26

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN SODIUM100 mg/1

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 "Extended Phenytoin Sodium" or generic name "Phenytoin Sodium"

NDCBrand NameGeneric Name
68084-376Extended Phenytoin SodiumExtended Phenytoin Sodium
68788-6968Extended Phenytoin SodiumExtended Phenytoin Sodium
70518-0231Extended Phenytoin SodiumExtended Phenytoin Sodium
0904-6187Extended Phenytoin SodiumExtended Phenytoin Sodium
10135-603Extended Phenytoin SodiumExtended Phenytoin Sodium
43063-492Extended Phenytoin SodiumExtended Phenytoin Sodium
50090-2089Extended Phenytoin SodiumExtended Phenytoin Sodium
50090-3165Extended Phenytoin SodiumExtended Phenytoin Sodium
50090-3142Extended Phenytoin SodiumExtended Phenytoin Sodium
53808-1040Extended Phenytoin SodiumExtended Phenytoin Sodium
55289-906EXTENDED PHENYTOIN SODIUMEXTENDED PHENYTOIN SODIUM
55648-720EXTENDED PHENYTOIN SODIUMEXTENDED PHENYTOIN SODIUM
64679-720EXTENDED PHENYTOIN SODIUMEXTENDED PHENYTOIN SODIUM
64725-0720EXTENDED PHENYTOIN SODIUMEXTENDED PHENYTOIN SODIUM
65162-212Extended Phenytoin SodiumExtended Phenytoin Sodium
65862-692Extended Phenytoin SodiumExtended Phenytoin Sodium
55154-7979Extended Phenytoin SodiumExtended Phenytoin Sodium
70518-2227Extended Phenytoin SodiumExtended Phenytoin Sodium
71335-1349Extended Phenytoin SodiumExtended Phenytoin Sodium
68180-561Extended Phenytoin SodiumExtended Phenytoin Sodium
71610-479Extended Phenytoin SodiumExtended Phenytoin Sodium
42291-772Extended Phenytoin SodiumExtended Phenytoin Sodium
0071-0369DilantinExtended Phenytoin Sodium
0071-3740DilantinExtended Phenytoin Sodium
0378-2670Phenytekextended phenytoin sodium
0378-3750Phenytekphenytoin sodium
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
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