NDC Code | 60687-396-09 |
Package Description | 80 BLISTER PACK in 1 CARTON (60687-396-09) / 1 TABLET in 1 BLISTER PACK (60687-396-11) |
Product NDC | 60687-396 |
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 | 20230601 |
Marketing Category Name | ANDA |
Application Number | ANDA210211 |
Manufacturer | American Health Packaging |
Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
Strength | 325; 5 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Opioid Agonist [EPC], Opioid Agonists [MoA] |
DEA Schedule | CII |