Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine HCl is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Cypress Pharmaceutical, Inc.. The primary component is Hydrocodone Bitartrate; Pseudoephedrine Hydrochloride; Chlorpheniramine Maleate.
| Product ID | 60258-876_030d7689-e7e1-4698-8731-9a53c06bf074 |
| NDC | 60258-876 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Hydrocodone Bitartrate, Chlorpheniramine Maleate, and Pseudoephedrine HCl |
| Generic Name | Hydrocodone Bitartrate, Chlorpheniramine Maleate, Pseudoephedrine Hydrochloride |
| Dosage Form | Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 2014-01-09 |
| Marketing Category | NDA / NDA |
| Application Number | NDA022439 |
| Labeler Name | Cypress Pharmaceutical, Inc. |
| Substance Name | HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE |
| Active Ingredient Strength | 5 mg/5mL; mg/5mL; mg/5mL |
| Pharm 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 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |