| Product NDC: | 0121-4771 |
| Proprietary Name: | Hydrocodone Bitartrate and Acetaminophen |
| Non Proprietary Name: | HYDROCODONE BITARTRATE and ACETAMINOPHEN |
| Active Ingredient(s): | 163; 5 mg/7.5mL; mg/7.5mL & nbsp; HYDROCODONE BITARTRATE and ACETAMINOPHEN |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0121-4771 |
| Labeler Name: | Pharmaceutical Associates, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040834 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20080818 |
| Package NDC: | 0121-4771-07 |
| Package Description: | 4 TRAY in 1 CASE (0121-4771-07) > 10 CUP, UNIT-DOSE in 1 TRAY > 7.5 mL in 1 CUP, UNIT-DOSE |
| NDC Code | 0121-4771-07 |
| Proprietary Name | Hydrocodone Bitartrate and Acetaminophen |
| Package Description | 4 TRAY in 1 CASE (0121-4771-07) > 10 CUP, UNIT-DOSE in 1 TRAY > 7.5 mL in 1 CUP, UNIT-DOSE |
| Product NDC | 0121-4771 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | HYDROCODONE BITARTRATE and ACETAMINOPHEN |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 20080818 |
| Marketing Category Name | ANDA |
| Labeler Name | Pharmaceutical Associates, Inc. |
| Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
| Strength Number | 163; 5 |
| Strength Unit | mg/7.5mL; mg/7.5mL |
| Pharmaceutical Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |