Sevelamer Hydrochloride

Orange BookUNIISPLATC V03AE02

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

Identification

ManufacturerAmerican Health Packaging

CountryUS (United States)

ATC codeV03AE02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6068744901
100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-449-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-449-11)

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": "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": "60687-449_26408f23-0427-1bed-e063-6394a90aa7c8",
  "productndc": "60687-449",
  "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": "20200122",
  "active_numerator_strength": "800"
}

Related drugs

Other records sharing ATC code V03AE02.

Access this data programmatically

Query Sevelamer Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs