NDC Code | 60258-876-16 |
Package Description | 480 mL in 1 BOTTLE (60258-876-16) |
Product NDC | 60258-876 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Hydrocodone Bitartrate, Chlorpheniramine Maleate, And Pseudoephedrine Hcl |
Non-Proprietary Name | Hydrocodone Bitartrate, Chlorpheniramine Maleate, Pseudoephedrine Hydrochloride |
Dosage Form | SOLUTION |
Usage | ORAL |
Start Marketing Date | 20140109 |
Marketing Category Name | NDA |
Application Number | NDA022439 |
Manufacturer | Cypress Pharmaceutical, Inc. |
Substance Name | HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE |
Strength | 5; 60; 4 |
Strength Unit | mg/5mL; mg/5mL; mg/5mL |
Pharmacy Classes | Opioid Agonist [EPC],Opioid Agonists [MoA],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] |
DEA Schedule | CII |