| NDC Code | 50383-804-04 | 
|---|
			| Package Description | 118 mL in 1 BOTTLE (50383-804-04) | 
|---|
			| Product NDC | 50383-804 | 
|---|
			| Product Type Name | HUMAN PRESCRIPTION DRUG | 
|---|
			| Proprietary Name | Promethazine Hydrochloride And Codeine Phosphate | 
|---|
			
			| Non-Proprietary Name | Promethazine Hydrochloride And Codeine Phosphate | 
|---|
			| Dosage Form | SOLUTION | 
|---|
			| Usage | ORAL | 
|---|
			| Start Marketing Date | 19970826 | 
|---|
			
			| Marketing Category Name | ANDA | 
|---|
			| Application Number | ANDA040151 | 
|---|
			| Manufacturer | Akorn | 
|---|
			| Substance Name | CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | 
|---|
			| Strength | 10; 6.25 | 
|---|
			| Strength Unit | mg/5mL; mg/5mL | 
|---|
			| Pharmacy Classes | Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS] | 
|---|
			| DEA Schedule | CV | 
|---|