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NDC 65162-0058-11 Sevelamer Carbonate 800 mg/1 Details
Sevelamer Carbonate 800 mg/1
Sevelamer Carbonate is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is SEVELAMER CARBONATE.
MedlinePlus Drug Summary
Sevelamer is used to control high blood levels of phosphorus in people with chronic kidney disease who are on dialysis (medical treatment to clean the blood when the kidneys are not working properly). Sevelamer is in a class of medications called phosphate binders. It binds phosphorus that you get from foods in your diet and prevents it from being absorbed into your blood stream.
Related Packages: 65162-0058-11Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Sevelamer
Product Information
| NDC | 65162-0058 |
|---|---|
| Product ID | 65162-058_9ac0ab22-bdaa-4978-8741-f811b16fca6f |
| Associated GPIs | 52800070050340 |
| GCN Sequence Number | 063473 |
| GCN Sequence Number Description | sevelamer carbonate TABLET 800 MG ORAL |
| HIC3 | C1A |
| HIC3 Description | ELECTROLYTE DEPLETERS |
| GCN | 99200 |
| HICL Sequence Number | 035262 |
| HICL Sequence Number Description | SEVELAMER CARBONATE |
| Brand/Generic | Generic |
| Proprietary Name | Sevelamer Carbonate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Sevelamer Carbonate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 800 |
| Active Ingredient Units | mg/1 |
| Substance Name | SEVELAMER CARBONATE |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Phosphate Binder [EPC], Phosphate Chelating Activity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA207288 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65162-0058-11 (65162005811)
| NDC Package Code | 65162-058-11 |
|---|---|
| Billing NDC | 65162005811 |
| Package | 1000 TABLET, FILM COATED in 1 BOTTLE (65162-058-11) |
| Marketing Start Date | 2017-11-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |