| Product NDC: | 63717-895 |
| Proprietary Name: | ZAMICET |
| Non Proprietary Name: | HYDROCODONE BITARTRATE and ACETAMINOPHEN |
| Active Ingredient(s): | 325; 10 mg/15mL; mg/15mL & nbsp; HYDROCODONE BITARTRATE and ACETAMINOPHEN |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 63717-895 |
| Labeler Name: | Hawthorn Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040834 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20080825 |
| Package NDC: | 63717-895-99 |
| Package Description: | 30 mL in 1 BOTTLE (63717-895-99) |
| NDC Code | 63717-895-99 |
| Proprietary Name | ZAMICET |
| Package Description | 30 mL in 1 BOTTLE (63717-895-99) |
| Product NDC | 63717-895 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | HYDROCODONE BITARTRATE and ACETAMINOPHEN |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 20080825 |
| Marketing Category Name | ANDA |
| Labeler Name | Hawthorn Pharmaceuticals, Inc. |
| Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
| Strength Number | 325; 10 |
| Strength Unit | mg/15mL; mg/15mL |
| Pharmaceutical Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |