NDC Code | 82111-518-01 |
Package Description | 3 BLISTER PACK in 1 CARTON (82111-518-01) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Product NDC | 82111-518 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Dartisla Odt |
Non-Proprietary Name | Glycopyrrolate Orally Disintegrating Tablets |
Dosage Form | TABLET, ORALLY DISINTEGRATING |
Usage | ORAL |
Start Marketing Date | 20220201 |
Marketing Category Name | NDA |
Application Number | NDA215019 |
Manufacturer | Edenbridge Pharmaceuticals LLC. |
Substance Name | GLYCOPYRROLATE |
Strength | 1.7 |
Strength Unit | mg/1 |
Pharmacy Classes | Anticholinergic [EPC], Cholinergic Antagonists [MoA] |