NDC Code | 63304-497-01 |
Package Description | 100 TABLET in 1 BOTTLE (63304-497-01) |
Product NDC | 63304-497 |
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 | 20180731 |
Marketing Category Name | ANDA |
Application Number | ANDA040826 |
Manufacturer | Sun Pharmaceutical Industries, Inc. |
Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
Strength | 325; 10 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Opioid Agonist [EPC], Opioid Agonists [MoA] |
DEA Schedule | CII |