NDC Code | 76519-1079-3 |
Package Description | 30 TABLET in 1 BOTTLE (76519-1079-3) |
Product NDC | 76519-1079 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Hydrocodone Bitartrate And Acetaminophen |
Non-Proprietary Name | Hydrocodone Bitartrate And Acetaminophen |
Dosage Form | TABLET |
Usage | ORAL |
Start Marketing Date | 20160128 |
Marketing Category Name | ANDA |
Application Number | ANDA090415 |
Manufacturer | H.J. Harkins Company, Inc. |
Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
Strength | 300; 7.5 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |
DEA Schedule | CII |