| 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] |