renvela

Generic: sevelamer carbonate

Labeler: genzyme corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name renvela
Generic Name sevelamer carbonate
Labeler genzyme corporation
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

sevelamer carbonate 2400 mg/1

Manufacturer
Genzyme Corporation

Identifiers & Regulatory

Product NDC 58468-0131
Product ID 58468-0131_cb4453a2-c47b-4352-839f-f022ac67368e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022318
Listing Expiration 2026-12-31
Marketing Start 2009-08-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 584680131
Hyphenated Format 58468-0131

Supplemental Identifiers

RxCUI
749206 749210 861370 861373 861375 861377
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 renvela (source: ndc)
Generic Name sevelamer carbonate (source: ndc)
Application Number NDA022318 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2400 mg/1
source: ndc
Packaging
  • 90 PACKET in 1 CARTON (58468-0131-2) / 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-1)
source: ndc

Packages (1)

58468-0131-2 90 PACKET in 1 CARTON (58468-0131-2) / 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-1)

Ingredients (1)

sevelamer carbonate (2400 mg/1)

Linked Drug Pages (1)

Renvela ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cb4453a2-c47b-4352-839f-f022ac67368e", "openfda": {"unii": ["9YCX42I8IU"], "rxcui": ["749206", "749210", "861370", "861373", "861375", "861377"], "spl_set_id": ["e6328460-a57b-450b-a48c-6dcd4b476360"], "manufacturer_name": ["Genzyme Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 PACKET in 1 CARTON (58468-0131-2)  / 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-1)", "package_ndc": "58468-0131-2", "marketing_start_date": "20090812"}], "brand_name": "Renvela", "product_id": "58468-0131_cb4453a2-c47b-4352-839f-f022ac67368e", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "58468-0131", "generic_name": "SEVELAMER CARBONATE", "labeler_name": "Genzyme Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Renvela", "active_ingredients": [{"name": "SEVELAMER CARBONATE", "strength": "2400 mg/1"}], "application_number": "NDA022318", "marketing_category": "NDA", "marketing_start_date": "20090812", "listing_expiration_date": "20261231"}