sevelamer carbonate

Generic: sevelamer carbonate

Labeler: sanofi-aventis u.s. llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name sevelamer carbonate
Generic Name sevelamer carbonate
Labeler sanofi-aventis u.s. llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sevelamer carbonate 800 mg/1

Manufacturer
Sanofi-Aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0955-1057
Product ID 0955-1057_42bdb389-5550-487c-aed2-c4e3afd239c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA022127
Listing Expiration 2026-12-31
Marketing Start 2023-07-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09551057
Hyphenated Format 0955-1057

Supplemental Identifiers

RxCUI
749206 861370 861375
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 NDA022127 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 270 TABLET, FILM COATED in 1 BOTTLE (0955-1057-30)
source: ndc

Packages (1)

0955-1057-30 270 TABLET, FILM COATED in 1 BOTTLE (0955-1057-30)

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": "42bdb389-5550-487c-aed2-c4e3afd239c8", "openfda": {"unii": ["9YCX42I8IU"], "rxcui": ["749206", "861370", "861375"], "spl_set_id": ["3abc32fe-1bfc-4759-8f7c-36095e221b06"], "manufacturer_name": ["Sanofi-Aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "270 TABLET, FILM COATED in 1 BOTTLE (0955-1057-30)", "package_ndc": "0955-1057-30", "marketing_start_date": "20230714"}], "brand_name": "Sevelamer Carbonate", "product_id": "0955-1057_42bdb389-5550-487c-aed2-c4e3afd239c8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "0955-1057", "generic_name": "Sevelamer Carbonate", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sevelamer Carbonate", "active_ingredients": [{"name": "SEVELAMER CARBONATE", "strength": "800 mg/1"}], "application_number": "NDA022127", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20230714", "listing_expiration_date": "20261231"}