| Product NDC: | 76181-001 |
| Proprietary Name: | hydrocodone bitartrate and acetaminophen |
| Non Proprietary Name: | hydrocodone bitartrate and acetaminophen |
| Active Ingredient(s): | 325; 7.5 mg/15mL; mg/15mL & nbsp; hydrocodone bitartrate and acetaminophen |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SYRUP |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 76181-001 |
| Labeler Name: | Talec Pharma, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040482 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20110801 |
| Package NDC: | 76181-001-25 |
| Package Description: | 473 mL in 1 BOTTLE, PLASTIC (76181-001-25) |
| NDC Code | 76181-001-25 |
| Proprietary Name | hydrocodone bitartrate and acetaminophen |
| Package Description | 473 mL in 1 BOTTLE, PLASTIC (76181-001-25) |
| Product NDC | 76181-001 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | hydrocodone bitartrate and acetaminophen |
| Dosage Form Name | SYRUP |
| Route Name | ORAL |
| Start Marketing Date | 20110801 |
| Marketing Category Name | ANDA |
| Labeler Name | Talec Pharma, LLC |
| Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
| Strength Number | 325; 7.5 |
| Strength Unit | mg/15mL; mg/15mL |
| Pharmaceutical Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |