NDC Code | 43386-118-03 |
Package Description | 30 TABLET in 1 BOTTLE (43386-118-03) |
Product NDC | 43386-118 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Hydrocodone Bitartrate And Homatropine Methylbromide |
Non-Proprietary Name | Hydrocodone Bitartrate And Homatropine Methylbromide |
Dosage Form | TABLET |
Usage | ORAL |
Start Marketing Date | 20140923 |
Marketing Category Name | ANDA |
Application Number | ANDA091528 |
Manufacturer | Lupin Pharmaceuticals,Inc. |
Substance Name | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
Strength | 1.5; 5 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Opioid Agonist [EPC], Opioid Agonists [MoA] |
DEA Schedule | CII |