Promethazine VC With Codeine - Codeine Phosphate, Promethazine Hydrochloride, and Phenylephrine Hydrochloride
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Field |
Value |
NDC Code: |
54569-1047 |
Proprietary Name: |
Promethazine VC With Codeine |
Suffix: |
|
Non-Proprietary Name: |
Codeine Phosphate, Promethazine Hydrochloride, and Phenylephrine Hydrochloride |
Dosage Form: |
SYRUP |
Method: |
ORAL |
Original Marketing Date: |
07-12-2006 |
Category Name: |
ANDA |
Application Number: |
ANDA040660 |
Labeler: |
A S MEDICATION SOLUTIONS LLC |
Substance Name: |
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE |
Active Numerator Strength: |
10; 5; 6.25 |
Active Ingredient Unit: |
mg/5mL; mg/5mL; mg/5mL |
Pharm Classes: |
Full Opioid Agonists [MoA],Opioid Agonist [EPC],Phenothiazine [EPC],Phenothiazines [Chemical/Ingredient] |
DEA Schedule: |
CV |