| Product NDC: | 42549-516 |
| Proprietary Name: | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| Non Proprietary Name: | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| Active Ingredient(s): | 500; 7.5 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: | 42549-516 |
| Labeler Name: | STAT Rx USA LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040201 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20100422 |
| Package NDC: | 42549-516-02 |
| Package Description: | 112 TABLET in 1 BOTTLE (42549-516-02) |
| NDC Code | 42549-516-02 |
| Proprietary Name | HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
| Package Description | 112 TABLET in 1 BOTTLE (42549-516-02) |
| Product NDC | 42549-516 |
| 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 | STAT Rx USA LLC |
| Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
| Strength Number | 500; 7.5 |
| Strength Unit | mg/1; mg/1 |
| Pharmaceutical Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |