Sevelamer Carbonate for Oral Suspension

Orange BookUNIISPLATC V03AE02

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

Identification

ManufacturerDr. Reddys Laboratories Inc

CountryUS (United States)

ATC codeV03AE02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4359847890
90 PACKET in 1 CARTON (43598-478-90) / 1 POWDER, FOR SUSPENSION in 1 PACKET (43598-478-01)

Annotations

UNII (FDA Substance ID)

9YCX42I8IU

SEVELAMER CARBONATE

RxCUI 660890

Orange Book

A210464

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": "43598-478_85e37025-d239-e504-38a0-c2db7ffa0100",
  "productndc": "43598-478",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "210464",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG/PACKET",
        "product_no": "001",
        "approval_date": "Oct 25, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.4GM/PACKET",
        "product_no": "002",
        "approval_date": "Oct 25, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SEVELAMER CARBONATE",
  "proprietary_name": "Sevelamer Carbonate for Oral Suspension",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210464",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sevelamer Carbonate for Oral Suspension",
  "start_marketing_date": "20181025",
  "active_numerator_strength": "800"
}

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