Roxicet is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp. The primary component is Oxycodone Hydrochloride; Acetaminophen.
| Product ID | 0054-8648_287496b8-2d45-4949-8194-d540281c2532 |
| NDC | 0054-8648 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Roxicet |
| Generic Name | Oxycodone And Acetaminophen |
| Dosage Form | Solution |
| Route of Administration | ORAL |
| Marketing Start Date | 1991-01-17 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA089351 |
| Labeler Name | West-Ward Pharmaceuticals Corp |
| Substance Name | OXYCODONE HYDROCHLORIDE; ACETAMINOPHEN |
| Active Ingredient Strength | 5 mg/5mL; mg/5mL |
| Pharm Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
| DEA Schedule | CII |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Category | ANDA |
| Application Number | ANDA089351 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1991-01-17 |
| Marketing End Date | 2014-07-02 |
| Inactivation Date | 2020-01-31 |
| Ingredient | Strength |
|---|---|
| OXYCODONE HYDROCHLORIDE | 5 mg/5mL |
| SPL SET ID: | 86817b05-450c-4af0-aeea-acba2ac00601 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0054-3686 | Roxicet | Oxycodone and Acetaminophen |
| 0054-4650 | Roxicet | Oxycodone and Acetaminophen |
| 0054-8648 | Roxicet | Oxycodone and Acetaminophen |
| 0054-8650 | Roxicet | Oxycodone and Acetaminophen |
| 0054-0551 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen |
| 0228-2981 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen |
| 0228-2982 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen |
| 0228-2983 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen |
| 0527-1669 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen |
| 0527-1671 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen |
| 0904-7093 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen |
| 0904-7094 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen |
| 0904-7095 | OXYCODONE AND ACETAMINOPHEN | oxycodone and acetaminophen |
| 10544-621 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen |
| 10702-184 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen |
| 10702-185 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen |
| 10702-186 | Oxycodone and Acetaminophen | Oxycodone and Acetaminophen |