Fosrenol

Orange BookUNIISPLATC V03AE03

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

Identification

ManufacturerTakeda Pharmaceuticals America, Inc.

CountryUS (United States)

ATC codeV03AE03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5409225490
9 BOTTLE in 1 PACKAGE (54092-254-90) / 10 TABLET, CHEWABLE in 1 BOTTLE (54092-254-10)

Annotations

UNII (FDA Substance ID)

490D9F069T

LANTHANUM CARBONATE

RxCUI 234416

Orange Book

N021468

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "490D9F069T",
    "rxcui": "234416",
    "inchikey": "PKOQIYFBOVTYOH-UHFFFAOYSA-H",
    "display_name": "LANTHANUM CARBONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f10776b2-2c25-4343-aabe-68f302e5cb54": {
      "match": "brand_token",
      "title": "FOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "58",
      "published_date": "2025-04-07"
    }
  },
  "productid": "54092-254_b29f2b53-6f45-447d-afb3-297ccc4ef8db",
  "productndc": "54092-254",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "021468",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 250MG BASE",
        "product_no": "001",
        "approval_date": "Oct 26, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 500MG BASE",
        "product_no": "002",
        "approval_date": "Oct 26, 2004"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 750MG BASE",
        "product_no": "003",
        "approval_date": "Nov 23, 2005"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 1GM BASE",
        "product_no": "004",
        "approval_date": "Nov 23, 2005"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LANTHANUM CARBONATE",
  "proprietary_name": "Fosrenol",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021468",
  "marketing_category": "NDA",
  "nonproprietary_name": "lanthanum carbonate",
  "start_marketing_date": "20051123",
  "active_numerator_strength": "1000"
}

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