NDC Code | 0574-1105-16 |
Package Description | 473 mL in 1 BOTTLE (0574-1105-16) |
Product NDC | 0574-1105 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Hydrocodone Bitartrate And Homatropine Methylbromide |
Non-Proprietary Name | Hydrocodone Bitartrate, Homatropine Methylbromide |
Dosage Form | SOLUTION |
Usage | ORAL |
Start Marketing Date | 20170616 |
End Marketing Date | 20190531 |
Marketing Category Name | ANDA |
Application Number | ANDA205731 |
Manufacturer | Paddock Laboratories, LLC |
Substance Name | HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE |
Strength | 5; 1.5 |
Strength Unit | mg/5mL; mg/5mL |
Pharmacy Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |
DEA Schedule | CII |