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United States · US · US:49230-645_4e6c954e-7710-efc7-e063-6394a90a6dc2

Velphoro

Orange BookUNIISPLATC V03AE05

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

Identification

ManufacturerFresenius Medical Care Renal Therapies Group, LLC
CountryUS (United States)
ATC codeV03AE05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4923064551
    1 BOTTLE in 1 CARTON (49230-645-51) / 90 TABLET, CHEWABLE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
87PZU03K0K
FERRIC OXYHYDROXIDE
RxCUI 1484283
Orange Book
N205109
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "87PZU03K0K",
    "rxcui": "1484283",
    "inchikey": "IEECXTSVVFWGSE-UHFFFAOYSA-M",
    "display_name": "FERRIC OXYHYDROXIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "237da26c-f38c-4faa-93ad-735e71c9d0c1": {
      "match": "brand_token",
      "title": "VELPHORO (SUCROFERRIC OXYHYDROXIDE) TABLET, CHEWABLE [FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC]",
      "spl_version": "37",
      "published_date": "2026-04-02"
    }
  },
  "productid": "49230-645_4e6c954e-7710-efc7-e063-6394a90a6dc2",
  "productndc": "49230-645",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "205109",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 500MG IRON",
        "product_no": "001",
        "approval_date": "Nov 27, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FERRIC OXYHYDROXIDE",
  "proprietary_name": "Velphoro",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA205109",
  "marketing_category": "NDA",
  "nonproprietary_name": "sucroferric oxyhydroxide",
  "start_marketing_date": "20131127",
  "active_numerator_strength": "500"
}

Related drugs

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