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 |