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United States · US · US:0955-1054_42bdb389-5550-487c-aed2-c4e3afd239c8

Sevelamer Carbonate

Orange BookUNIISPLATC V03AE02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSanofi-Aventis U.S. LLC
CountryUS (United States)
ATC codeV03AE02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0955105490
    90 PACKET in 1 BOX (0955-1054-90) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0955-1054-01)

Annotations

UNII (FDA Substance ID)
9YCX42I8IU
SEVELAMER CARBONATE
RxCUI 660890
Orange Book
N022318
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9YCX42I8IU",
    "rxcui": "660890",
    "inchikey": null,
    "display_name": "SEVELAMER CARBONATE",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "51ce2ed6-3acf-a6ea-e063-6294a90a21aa": {
      "match": "brand_token",
      "title": "SEVELAMER CARBONATE TABLET, FILM COATED [INSIGNAMEDEX LLC]",
      "spl_version": "2",
      "published_date": "2026-05-25"
    }
  },
  "productid": "0955-1054_42bdb389-5550-487c-aed2-c4e3afd239c8",
  "productndc": "0955-1054",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "022318",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "800MG/PACKET",
        "product_no": "001",
        "approval_date": "Aug 12, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "2.4GM/PACKET",
        "product_no": "002",
        "approval_date": "Feb 18, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SEVELAMER CARBONATE",
  "proprietary_name": "Sevelamer Carbonate",
  "active_ingred_unit": "g/1",
  "application_number": "NDA022318",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Sevelamer Carbonate",
  "start_marketing_date": "20180101",
  "active_numerator_strength": "2.4"
}

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