sevelamer carbonate

Generic: sevelamer carbonate

Labeler: shandong xinhua pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sevelamer carbonate
Generic Name sevelamer carbonate
Labeler shandong xinhua pharmaceutical co., ltd.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sevelamer carbonate 800 mg/1

Manufacturer
Shandong Xinhua Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 58624-5001
Product ID 58624-5001_ff5f602e-c050-40d7-81f5-1c8dfba1d32f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215998
Listing Expiration 2026-12-31
Marketing Start 2025-02-27

Pharmacologic Class

Classes
phosphate binder [epc] phosphate chelating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 586245001
Hyphenated Format 58624-5001

Supplemental Identifiers

RxCUI
749206
UNII
9YCX42I8IU

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sevelamer carbonate (source: ndc)
Generic Name sevelamer carbonate (source: ndc)
Application Number ANDA215998 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (58624-5001-2)
  • 18399 TABLET, FILM COATED in 1 CARTON (58624-5001-4)
source: ndc

Packages (2)

58624-5001-2 30 TABLET, FILM COATED in 1 BOTTLE (58624-5001-2) 58624-5001-4 18399 TABLET, FILM COATED in 1 CARTON (58624-5001-4)

Ingredients (1)

sevelamer carbonate (800 mg/1)

Linked Drug Pages (1)

SEVELAMER CARBONATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ff5f602e-c050-40d7-81f5-1c8dfba1d32f", "openfda": {"unii": ["9YCX42I8IU"], "rxcui": ["749206"], "spl_set_id": ["f6455fa3-ad53-f6fd-e053-2a95a90a67db"], "manufacturer_name": ["Shandong Xinhua Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (58624-5001-2)", "package_ndc": "58624-5001-2", "marketing_start_date": "20250227"}, {"sample": false, "description": "18399 TABLET, FILM COATED in 1 CARTON (58624-5001-4)", "package_ndc": "58624-5001-4", "marketing_start_date": "20250227"}], "brand_name": "SEVELAMER CARBONATE", "product_id": "58624-5001_ff5f602e-c050-40d7-81f5-1c8dfba1d32f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "58624-5001", "generic_name": "SEVELAMER CARBONATE", "labeler_name": "Shandong Xinhua Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SEVELAMER CARBONATE", "active_ingredients": [{"name": "SEVELAMER CARBONATE", "strength": "800 mg/1"}], "application_number": "ANDA215998", "marketing_category": "ANDA", "marketing_start_date": "20250227", "listing_expiration_date": "20261231"}