| Product NDC: | 67544-025 | 
| Proprietary Name: | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 
| Non Proprietary Name: | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 
| Active Ingredient(s): | 500; 10 mg/1; mg/1 & nbsp; HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | TABLET | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 67544-025 | 
| Labeler Name: | Aphena Pharma Solutions - Tennessee, Inc. | 
| Product Type: | HUMAN PRESCRIPTION DRUG | 
| FDA Application Number: | ANDA040201 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20100422 | 
| Package NDC: | 67544-025-70 | 
| Package Description: | 120 TABLET in 1 BOTTLE, PLASTIC (67544-025-70) | 
| NDC Code | 67544-025-70 | 
| Proprietary Name | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 
| Package Description | 120 TABLET in 1 BOTTLE, PLASTIC (67544-025-70) | 
| Product NDC | 67544-025 | 
| Product Type Name | HUMAN PRESCRIPTION DRUG | 
| Non Proprietary Name | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 
| Dosage Form Name | TABLET | 
| Route Name | ORAL | 
| Start Marketing Date | 20100422 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Aphena Pharma Solutions - Tennessee, Inc. | 
| Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 
| Strength Number | 500; 10 | 
| Strength Unit | mg/1; mg/1 | 
| Pharmaceutical Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |