| Product NDC: | 54868-0860 |
| Proprietary Name: | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| Non Proprietary Name: | acetaminophen and codeine phosphate |
| Active Ingredient(s): | 300; 60 mg/1; mg/1 & nbsp; acetaminophen and codeine phosphate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 54868-0860 |
| Labeler Name: | Physicians Total Care, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040419 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20090708 |
| Package NDC: | 54868-0860-3 |
| Package Description: | 90 TABLET in 1 BOTTLE (54868-0860-3) |
| NDC Code | 54868-0860-3 |
| Proprietary Name | ACETAMINOPHEN AND CODEINE PHOSPHATE |
| Package Description | 90 TABLET in 1 BOTTLE (54868-0860-3) |
| Product NDC | 54868-0860 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | acetaminophen and codeine phosphate |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20090708 |
| Marketing Category Name | ANDA |
| Labeler Name | Physicians Total Care, Inc. |
| Substance Name | ACETAMINOPHEN; CODEINE PHOSPHATE |
| Strength Number | 300; 60 |
| Strength Unit | mg/1; mg/1 |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |