Product NDC: | 52584-555 |
Proprietary Name: | Phenytoin Sodium |
Non Proprietary Name: | Phenytoin Sodium |
Active Ingredient(s): | 250 mg/5mL & nbsp; Phenytoin Sodium |
Administration Route(s): | INTRAMUSCULAR; INTRAVENOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 52584-555 |
Labeler Name: | General Injectables & Vaccines, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA084307 |
Marketing Category: | ANDA |
Start Marketing Date: | 20110830 |
Package NDC: | 52584-555-41 |
Package Description: | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-555-41) > 5 mL in 1 VIAL, SINGLE-DOSE |
NDC Code | 52584-555-41 |
Proprietary Name | Phenytoin Sodium |
Package Description | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-555-41) > 5 mL in 1 VIAL, SINGLE-DOSE |
Product NDC | 52584-555 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Phenytoin Sodium |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAMUSCULAR; INTRAVENOUS |
Start Marketing Date | 20110830 |
Marketing Category Name | ANDA |
Labeler Name | General Injectables & Vaccines, Inc. |
Substance Name | PHENYTOIN SODIUM |
Strength Number | 250 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE] |