Hydrocodone Bitartrate, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Paddock Laboratories, Llc. The primary component is Hydrocodone Bitartrate; Chlorpheniramine Maleate; Pseudoephedrine Hydrochloride.
| Product ID | 0574-1103_766fa673-6f1b-4731-b025-551c1c862c60 |
| NDC | 0574-1103 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Hydrocodone Bitartrate, Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride |
| Generic Name | Hydrocodone Bitartrate, Chlorpheniramine Maleate And Pseudoephedrine Hydrochloride |
| Dosage Form | Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 2014-08-26 |
| Marketing End Date | 2019-10-31 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA204627 |
| Labeler Name | Paddock Laboratories, LLC |
| Substance Name | HYDROCODONE BITARTRATE; CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Active Ingredient Strength | 5 mg/5mL; mg/5mL; mg/5mL |
| Pharm 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 |
| NDC Exclude Flag | N |