NDC 0955-1048
Sevelamer Hydrochloride
Sevelamer Hydrochloride
Sevelamer Hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Winthrop U.s.. The primary component is Sevelamer Hydrochloride.
| Product ID | 0955-1048_65e36e3d-4650-4f33-b233-7e89ef511093 |
| NDC | 0955-1048 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Sevelamer Hydrochloride |
| Generic Name | Sevelamer Hydrochloride |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-02-13 |
| Marketing Category | NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC |
| Application Number | NDA021179 |
| Labeler Name | Winthrop U.S. |
| Substance Name | SEVELAMER HYDROCHLORIDE |
| Active Ingredient Strength | 800 mg/1 |
| Pharm Classes | Phosphate Binder [EPC],Phosphate Chelating Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |