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United States · US · US:55154-2647_cd703ad5-7d31-462e-971e-44bd794498ba

sevelamer hydrochloride

Orange BookUNIISPLATC V03AE02

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

Identification

ManufacturerCardinal Health 107, LLC
CountryUS (United States)
ATC codeV03AE02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5515426470
    10 BLISTER PACK in 1 BAG (55154-2647-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
GLS2PGI8QG
SEVELAMER HYDROCHLORIDE
RxCUI 237125
Orange Book
A204724
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "GLS2PGI8QG",
    "rxcui": "237125",
    "inchikey": null,
    "display_name": "SEVELAMER HYDROCHLORIDE",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "PARENTERAL",
  "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": "55154-2647_cd703ad5-7d31-462e-971e-44bd794498ba",
  "productndc": "55154-2647",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "204724",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Feb 8, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "002",
        "approval_date": "Feb 8, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SEVELAMER HYDROCHLORIDE",
  "proprietary_name": "sevelamer hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204724",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sevelamer hydrochloride",
  "start_marketing_date": "20250225",
  "active_numerator_strength": "800"
}

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