| NDC Code: |
52125-596 |
| Proprietary Name: |
Prometh with Codeine |
| Suffix: |
|
| Non-Proprietary Name: |
promethazine hydrochloride and codeine phosphate |
| Dosage Form: |
SYRUP |
| Method: |
ORAL |
| Original Marketing Date: |
08-07-2013 |
| Category Name: |
ANDA |
| Application Number: |
ANDA088763 |
| Labeler: |
REMEDYREPACK INC. |
| Substance Name: |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
| Active Numerator Strength: |
10; 6.25 |
| Active Ingredient Unit: |
mg/5mL; mg/5mL |
| Pharm Classes: |
Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] |
| DEA Schedule: |
|
