Promethazine with Codeine - Promethazine Hydrochloride and Codeine Phosphate
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Field |
Value |
NDC Code: |
0603-1585 |
Proprietary Name: |
Promethazine with Codeine |
Suffix: |
|
Non-Proprietary Name: |
Promethazine Hydrochloride and Codeine Phosphate |
Dosage Form: |
SYRUP |
Method: |
ORAL |
Original Marketing Date: |
31-01-2006 |
Category Name: |
ANDA |
Application Number: |
ANDA040650 |
Labeler: |
QUALITEST PHARMACEUTICALS |
Substance Name: |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
Active Numerator Strength: |
10; 6.25 |
Active Ingredient Unit: |
mg/5mL; mg/5mL |
Pharm Classes: |
Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient],Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
DEA Schedule: |
CV |