NDC Code | 0713-0879-81 |
Package Description | 180 TABLET, FILM COATED in 1 BOTTLE (0713-0879-81) |
Product NDC | 0713-0879 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Welchol |
Non-Proprietary Name | Colesevelam Hydrochloride |
Dosage Form | TABLET, FILM COATED |
Usage | ORAL |
Start Marketing Date | 20220901 |
Marketing Category Name | NDA |
Application Number | NDA021176 |
Manufacturer | Cosette Pharmaceuticals, Inc. |
Substance Name | COLESEVELAM HYDROCHLORIDE |
Strength | 625 |
Strength Unit | mg/1 |
Pharmacy Classes | Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA] |