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Roxicet
Roxicet - 0054-8648-16 - (Oxycodone and Acetaminophen)
Drug Information of Roxicet
| Product NDC: | 0054-8648 |
| Proprietary Name: | Roxicet |
| Non Proprietary Name: | Oxycodone and Acetaminophen |
| Active Ingredient(s): | 325; 5 mg/5mL; mg/5mL & nbsp; Oxycodone and Acetaminophen |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Roxicet
| Product NDC: | 0054-8648 |
| Labeler Name: | Roxane Laboratories, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA089351 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 19910117 |
Package Information of Roxicet
| Package NDC: | 0054-8648-16 |
| Package Description: | 10 CUP, UNIT-DOSE in 1 CARTON (0054-8648-16) > 5 mL in 1 CUP, UNIT-DOSE |
NDC Information of Roxicet
| NDC Code | 0054-8648-16 |
| Proprietary Name | Roxicet |
| Package Description | 10 CUP, UNIT-DOSE in 1 CARTON (0054-8648-16) > 5 mL in 1 CUP, UNIT-DOSE |
| Product NDC | 0054-8648 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Oxycodone and Acetaminophen |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 19910117 |
| Marketing Category Name | ANDA |
| Labeler Name | Roxane Laboratories, Inc. |
| Substance Name | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
| Strength Number | 325; 5 |
| Strength Unit | mg/5mL; mg/5mL |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
