Promethazine HCl, Phenylephrine HCl, Codeine Phosphate is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Promethazine Hydrochloride; Phenylephrine Hydrochloride; Codeine Phosphate.
| Product ID | 65162-694_2a583446-486f-46c9-a568-f1b760d8a9b1 |
| NDC | 65162-694 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Promethazine HCl, Phenylephrine HCl, Codeine Phosphate |
| Generic Name | Promethazine, Phenylephrine, Codeine |
| Dosage Form | Syrup |
| Route of Administration | ORAL |
| Marketing Start Date | 2013-11-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA200963 |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Substance Name | PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; CODEINE PHOSPHATE |
| Active Ingredient Strength | 6 mg/5mL; mg/5mL; mg/5mL |
| Pharm Classes | Phenothiazine [EPC],Phenothiazines [CS],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA],Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
| DEA Schedule | CV |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
| Marketing Start Date | 2013-11-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA200963 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2013-11-01 |
| Marketing Category | ANDA |
| Application Number | ANDA200963 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2013-11-01 |
| Ingredient | Strength |
|---|---|
| PROMETHAZINE HYDROCHLORIDE | 6.25 mg/5mL |
| SPL SET ID: | 5f23b254-872b-4e88-91be-710c3ea7687b |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |