Product NDC: | 0603-9013 |
Proprietary Name: | Acetaminophen And Codeine |
Non Proprietary Name: | Acetaminophen and Codeine Phosphate |
Active Ingredient(s): | 120; 12 mg/5mL; mg/5mL & nbsp; Acetaminophen and Codeine Phosphate |
Administration Route(s): | ORAL |
Dosage Form(s): | SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0603-9013 |
Labeler Name: | Qualitest Pharmaceuticals |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA091238 |
Marketing Category: | ANDA |
Start Marketing Date: | 20111110 |
Package NDC: | 0603-9013-58 |
Package Description: | 473 mL in 1 BOTTLE (0603-9013-58) |
NDC Code | 0603-9013-58 |
Proprietary Name | Acetaminophen And Codeine |
Package Description | 473 mL in 1 BOTTLE (0603-9013-58) |
Product NDC | 0603-9013 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Acetaminophen and Codeine Phosphate |
Dosage Form Name | SOLUTION |
Route Name | ORAL |
Start Marketing Date | 20111110 |
Marketing Category Name | ANDA |
Labeler Name | Qualitest Pharmaceuticals |
Substance Name | ACETAMINOPHEN; CODEINE PHOSPHATE |
Strength Number | 120; 12 |
Strength Unit | mg/5mL; mg/5mL |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |