Product NDC: | 66689-036 |
Proprietary Name: | Phenytoin |
Non Proprietary Name: | Phenytoin |
Active Ingredient(s): | 125 mg/5mL & nbsp; Phenytoin |
Administration Route(s): | ORAL |
Dosage Form(s): | SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 66689-036 |
Labeler Name: | VistaPharm Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA040342 |
Marketing Category: | ANDA |
Start Marketing Date: | 20100510 |
Package NDC: | 66689-036-50 |
Package Description: | 5 TRAY in 1 CASE (66689-036-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 4 mL in 1 CUP, UNIT-DOSE (66689-036-01) |
NDC Code | 66689-036-50 |
Proprietary Name | Phenytoin |
Package Description | 5 TRAY in 1 CASE (66689-036-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 4 mL in 1 CUP, UNIT-DOSE (66689-036-01) |
Product NDC | 66689-036 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Phenytoin |
Dosage Form Name | SUSPENSION |
Route Name | ORAL |
Start Marketing Date | 20100510 |
Marketing Category Name | ANDA |
Labeler Name | VistaPharm Inc. |
Substance Name | PHENYTOIN |
Strength Number | 125 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |