NDC Code | 0574-1103-16 |
Package Description | 480 mL in 1 BOTTLE, PLASTIC (0574-1103-16) |
Product NDC | 0574-1103 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Hydrocodone Bitartrate, Chlorpheniramine Maleate And Pseudoephedrine Hydrochloride |
Non-Proprietary Name | Hydrocodone Bitartrate, Chlorpheniramine Maleate And Pseudoephedrine Hydrochloride |
Dosage Form | SOLUTION |
Usage | ORAL |
Start Marketing Date | 20140826 |
End Marketing Date | 20191031 |
Marketing Category Name | ANDA |
Application Number | ANDA204627 |
Manufacturer | Paddock Laboratories, LLC |
Substance Name | HYDROCODONE BITARTRATE; CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
Strength | 5; 4; 60 |
Strength Unit | mg/5mL; mg/5mL; mg/5mL |
Pharmacy Classes | Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC] |
DEA Schedule | CII |