NDC Code | 53002-3401-2 |
Package Description | 20 TABLET in 1 BOTTLE (53002-3401-2) |
Product NDC | 53002-3401 |
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 | 20200315 |
Marketing Category Name | ANDA |
Application Number | ANDA213413 |
Manufacturer | RPK 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 |