Product NDC: | 63323-494 |
Proprietary Name: | Valproate |
Non Proprietary Name: | VALPROIC ACID |
Active Ingredient(s): | 100 mg/mL & nbsp; VALPROIC ACID |
Administration Route(s): | INTRAVENOUS |
Dosage Form(s): | INJECTION, SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 63323-494 |
Labeler Name: | APP Pharmaceuticals, LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA076539 |
Marketing Category: | ANDA |
Start Marketing Date: | 20030818 |
Package NDC: | 63323-494-05 |
Package Description: | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-494-05) > 5 mL in 1 VIAL, SINGLE-DOSE |
NDC Code | 63323-494-05 |
Proprietary Name | Valproate |
Package Description | 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-494-05) > 5 mL in 1 VIAL, SINGLE-DOSE |
Product NDC | 63323-494 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | VALPROIC ACID |
Dosage Form Name | INJECTION, SOLUTION |
Route Name | INTRAVENOUS |
Start Marketing Date | 20030818 |
Marketing Category Name | ANDA |
Labeler Name | APP Pharmaceuticals, LLC |
Substance Name | VALPROIC ACID |
Strength Number | 100 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC] |