| NDC Code | 62559-490-01 |
|---|
| Package Description | 100 TABLET in 1 BOTTLE (62559-490-01) |
|---|
| Product NDC | 62559-490 |
|---|
| 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 | 20170707 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA086727 |
|---|
| Manufacturer | ANI 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 |
|---|