Product NDC: | 63717-877 |
Proprietary Name: | Vituz |
Non Proprietary Name: | Hydrocodone Bitartrate, and Chlorpheniramine Maleate |
Active Ingredient(s): | 4; 5 mg/5mL; mg/5mL & nbsp; Hydrocodone Bitartrate, and Chlorpheniramine Maleate |
Administration Route(s): | ORAL |
Dosage Form(s): | SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 63717-877 |
Labeler Name: | Hawthorn Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA204307 |
Marketing Category: | NDA |
Start Marketing Date: | 20130401 |
Package NDC: | 63717-877-16 |
Package Description: | 480 mL in 1 BOTTLE (63717-877-16) |
NDC Code | 63717-877-16 |
Proprietary Name | Vituz |
Package Description | 480 mL in 1 BOTTLE (63717-877-16) |
Product NDC | 63717-877 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Hydrocodone Bitartrate, and Chlorpheniramine Maleate |
Dosage Form Name | SOLUTION |
Route Name | ORAL |
Start Marketing Date | 20130401 |
Marketing Category Name | NDA |
Labeler Name | Hawthorn Pharmaceuticals, Inc. |
Substance Name | CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE |
Strength Number | 4; 5 |
Strength Unit | mg/5mL; mg/5mL |
Pharmaceutical Classes | Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] |