Product NDC: | 68094-533 |
Proprietary Name: | Phenytoin |
Non Proprietary Name: | Phenytoin |
Active Ingredient(s): | 100 mg/4mL & nbsp; Phenytoin |
Administration Route(s): | ORAL |
Dosage Form(s): | SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 68094-533 |
Labeler Name: | Precision Dose, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA040420 |
Marketing Category: | ANDA |
Start Marketing Date: | 20040205 |
Package NDC: | 68094-533-58 |
Package Description: | 5 BAG in 1 CASE (68094-533-58) > 10 SYRINGE, PLASTIC in 1 BAG > 4 mL in 1 SYRINGE, PLASTIC |
NDC Code | 68094-533-58 |
Proprietary Name | Phenytoin |
Package Description | 5 BAG in 1 CASE (68094-533-58) > 10 SYRINGE, PLASTIC in 1 BAG > 4 mL in 1 SYRINGE, PLASTIC |
Product NDC | 68094-533 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Phenytoin |
Dosage Form Name | SUSPENSION |
Route Name | ORAL |
Start Marketing Date | 20040205 |
Marketing Category Name | ANDA |
Labeler Name | Precision Dose, Inc. |
Substance Name | PHENYTOIN |
Strength Number | 100 |
Strength Unit | mg/4mL |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |