0713-0823Level 3
Promethazine Hydrochloride and Codeine Phosphate (Promethazine Hydrochloride and Codeine Phosphate)
**Product type:** Human Prescription Drug
**Active ingredient:** CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
**Strength:** 10; 6.25 mg/5mL; mg/5mL
**Dosage form:** Solution
**Route:** Oral
**Labeler:** Cosette Pharmaceuticals, Inc.
**Marketing category:** ANDA (ANDA200386)
**Pharmacologic class:** Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS]
**DEA schedule:** CV
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