Product NDC: | 39822-4050 |
Proprietary Name: | PHENYTOIN SODIUM |
Non Proprietary Name: | PHENYTOIN SODIUM |
Active Ingredient(s): | 50 mg/mL & nbsp; PHENYTOIN SODIUM |
Administration Route(s): | INTRAMUSCULAR; INTRAVENOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 39822-4050 |
Labeler Name: | X-GEN Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA040573 |
Marketing Category: | ANDA |
Start Marketing Date: | 20110502 |
Package NDC: | 39822-4050-6 |
Package Description: | 25 VIAL, SINGLE-DOSE in 1 CARTON (39822-4050-6) > 10 mL in 1 VIAL, SINGLE-DOSE (39822-4050-5) |
NDC Code | 39822-4050-6 |
Proprietary Name | PHENYTOIN SODIUM |
Package Description | 25 VIAL, SINGLE-DOSE in 1 CARTON (39822-4050-6) > 10 mL in 1 VIAL, SINGLE-DOSE (39822-4050-5) |
Product NDC | 39822-4050 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | PHENYTOIN SODIUM |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAMUSCULAR; INTRAVENOUS |
Start Marketing Date | 20110502 |
Marketing Category Name | ANDA |
Labeler Name | X-GEN Pharmaceuticals, Inc. |
Substance Name | PHENYTOIN SODIUM |
Strength Number | 50 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |