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United States · US · US:54092-257_b29f2b53-6f45-447d-afb3-297ccc4ef8db

Fosrenol

Orange BookUNIISPLATC V03AE03

Last synced from FDA National Drug Code directory (United States) on

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
    5409225702
    9 CARTON in 1 CARTON (54092-257-02) / 10 POWDER in 1 CARTON (54092-257-01)

Annotations

UNII (FDA Substance ID)
490D9F069T
LANTHANUM CARBONATE
RxCUI 234416
Orange Book
N204734
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": "54092-257_b29f2b53-6f45-447d-afb3-297ccc4ef8db",
  "productndc": "54092-257",
  "dosage_form": "POWDER",
  "orange_book": {
    "appl_no": "204734",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 750MG BASE",
        "product_no": "001",
        "approval_date": "Sep 24, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1GM BASE",
        "product_no": "002",
        "approval_date": "Sep 24, 2014"
      }
    ],
    "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": "NDA204734",
  "marketing_category": "NDA",
  "nonproprietary_name": "lanthanum carbonate",
  "start_marketing_date": "20140924",
  "active_numerator_strength": "1000"
}

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