NDC Code | 0121-0772-04 |
Package Description | 118 mL in 1 BOTTLE (0121-0772-04) |
Product NDC | 0121-0772 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Hydrocodone Bitartrate And Acetaminophen |
Non-Proprietary Name | Hydrocodone Bitartrate And Acetaminophen |
Dosage Form | SOLUTION |
Usage | ORAL |
Start Marketing Date | 20130729 |
Marketing Category Name | ANDA |
Application Number | ANDA040838 |
Manufacturer | PAI Holdings, LLC dba PAI Pharma |
Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
Strength | 325; 7.5 |
Strength Unit | mg/15mL; mg/15mL |
Pharmacy Classes | Opioid Agonist [EPC], Opioid Agonists [MoA] |
DEA Schedule | CII |