| Product NDC: | 0054-0245 |
| Proprietary Name: | Codeine sulfate |
| Non Proprietary Name: | codeine sulfate |
| Active Ingredient(s): | 60 mg/1 & nbsp; codeine sulfate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0054-0245 |
| Labeler Name: | Roxane Laboratories, Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022402 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20091001 |
| Package NDC: | 0054-0245-25 |
| Package Description: | 100 TABLET in 1 BOTTLE (0054-0245-25) |
| NDC Code | 0054-0245-25 |
| Proprietary Name | Codeine sulfate |
| Package Description | 100 TABLET in 1 BOTTLE (0054-0245-25) |
| Product NDC | 0054-0245 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | codeine sulfate |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20091001 |
| Marketing Category Name | NDA |
| Labeler Name | Roxane Laboratories, Inc |
| Substance Name | CODEINE SULFATE |
| Strength Number | 60 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |