NDC 65862-692

Extended Phenytoin Sodium

Phenytoin Sodium

Extended Phenytoin Sodium is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is Phenytoin Sodium.

Product ID65862-692_00bf4228-59f0-4cd6-bb2c-f3feed9dd230
NDC65862-692
Product TypeHuman Prescription Drug
Proprietary NameExtended Phenytoin Sodium
Generic NamePhenytoin Sodium
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2015-06-10
Marketing CategoryANDA / DRUG FOR FURTHER PROCESSING
Application NumberANDA204309
Labeler NameAurobindo Pharma Limited
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 Through2021-12-31

Packaging

NDC 65862-692-01

100 CAPSULE in 1 BOTTLE (65862-692-01)
Marketing Start Date2015-06-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65862-692-99 [65862069299]

Extended Phenytoin Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA204309
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-06-10

NDC 65862-692-10 [65862069210]

Extended Phenytoin Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA204309
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-06-10

NDC 65862-692-01 [65862069201]

Extended Phenytoin Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA204309
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-06-10

NDC 65862-692-78 [65862069278]

Extended Phenytoin Sodium CAPSULE
Marketing CategoryANDA
Application NumberANDA204309
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-06-10

Drug Details

Active Ingredients

IngredientStrength
PHENYTOIN SODIUM100 mg/1

Medicade Reported Pricing

65862069299 PHENYTOIN SOD EXT 100 MG CAP

Pricing Unit: EA | Drug Type:

65862069201 PHENYTOIN SOD EXT 100 MG CAP

Pricing Unit: EA | Drug Type:

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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.