NDC Code | 54766-200-10 |
Package Description | 100 TABLET in 1 BOTTLE (54766-200-10) |
Product NDC | 54766-200 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Motofen |
Non-Proprietary Name | Difenoxin And Atropine Sulfate |
Dosage Form | TABLET |
Usage | ORAL |
Start Marketing Date | 20170411 |
Marketing Category Name | NDA |
Application Number | NDA017744 |
Manufacturer | Sebela Pharmaceuticals Inc. |
Substance Name | ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE |
Strength | .025; 1 |
Strength Unit | mg/1; mg/1 |
Pharmacy Classes | Anticholinergic [EPC], Antidiarrheal [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA] |
DEA Schedule | CIV |