| Product NDC: | 68094-761 |
| Proprietary Name: | Codeine Sulfate |
| Non Proprietary Name: | Codeine Sulfate |
| Active Ingredient(s): | 30 mg/5mL & nbsp; Codeine Sulfate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 68094-761 |
| Labeler Name: | Precision Dose Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA202245 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20130226 |
| Package NDC: | 68094-761-62 |
| Package Description: | 3 TRAY in 1 CASE (68094-761-62) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-761-59) |
| NDC Code | 68094-761-62 |
| Proprietary Name | Codeine Sulfate |
| Package Description | 3 TRAY in 1 CASE (68094-761-62) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-761-59) |
| Product NDC | 68094-761 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Codeine Sulfate |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 20130226 |
| Marketing Category Name | NDA |
| Labeler Name | Precision Dose Inc. |
| Substance Name | CODEINE SULFATE |
| Strength Number | 30 |
| Strength Unit | mg/5mL |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |