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] |