SEVELAMER HYDROCHLORIDE

Orange BookUNIISPLATC V03AE02

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeV03AE02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5965108818
180 TABLET, FILM COATED in 1 BOTTLE (59651-088-18)

Annotations

UNII (FDA Substance ID)

GLS2PGI8QG

SEVELAMER HYDROCHLORIDE

RxCUI 237125

Orange Book

A212599

BXBX

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": "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": "59651-088_7a6f6abf-8a91-423e-8f2f-de1b3a019e7b",
  "productndc": "59651-088",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "212599",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Jul 11, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "BX",
        "strength": "800MG",
        "product_no": "002",
        "approval_date": "Jul 11, 2023"
      }
    ],
    "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": "ANDA212599",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SEVELAMER HYDROCHLORIDE",
  "start_marketing_date": "20230711",
  "active_numerator_strength": "800"
}

Related drugs

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