NDC Code | 0378-0415-10 |
Package Description | 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0415-10) |
Product NDC | 0378-0415 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Diphenoxylate Hydrochloride And Atropine Sulfate |
Non-Proprietary Name | Diphenoxylate Hydrochloride And Atropine Sulfate |
Dosage Form | TABLET |
Usage | ORAL |
Start Marketing Date | 19771117 |
End Marketing Date | 20240331 |
Marketing Category Name | ANDA |
Application Number | ANDA085762 |
Manufacturer | Mylan Pharmaceuticals Inc. |
Substance Name | ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE |
Strength | .025; 2.5 |
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 | CV |