SEVELAMER CARBONATE

Orange BookUNIISPLATC V03AE02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerStrides Pharma Science Limited

CountryUS (United States)

ATC codeV03AE02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6438088180
90 PACKET in 1 CARTON (64380-881-80) / 2400 mg in 1 PACKET (64380-881-00)

Annotations

UNII (FDA Substance ID)

9YCX42I8IU

SEVELAMER CARBONATE

RxCUI 660890

Orange Book

A211917

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": "64380-881_f0d25733-65a5-4143-a027-3412ff7a167d",
  "productndc": "64380-881",
  "dosage_form": "FOR SUSPENSION",
  "orange_book": {
    "appl_no": "211917",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG/PACKET",
        "product_no": "001",
        "approval_date": "Sep 8, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.4GM/PACKET",
        "product_no": "002",
        "approval_date": "Sep 8, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SEVELAMER CARBONATE",
  "proprietary_name": "SEVELAMER CARBONATE",
  "active_ingred_unit": "mg/2790mg",
  "application_number": "ANDA211917",
  "marketing_category": "ANDA",
  "nonproprietary_name": "sevelamer carbonate",
  "start_marketing_date": "20240202",
  "active_numerator_strength": "2400"
}

Related drugs

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