DEFERASIROX

Orange BookUNIISPLATC V03AC03

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeV03AC03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5965144930
30 PACKET in 1 CARTON (59651-449-30) / 1 GRANULE in 1 PACKET (59651-449-54)

Annotations

UNII (FDA Substance ID)

V8G4MOF2V9

DEFERASIROX

RxCUI 614373

Orange Book

A215137

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "V8G4MOF2V9",
    "rxcui": "614373",
    "inchikey": "BOFQWVMAQOTZIW-UHFFFAOYSA-N",
    "display_name": "DEFERASIROX",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a03c7657-fdca-4acb-ad82-c24680e90eae": {
      "match": "brand_token",
      "title": "DEFERASIROX TABLET, FOR SUSPENSION [NOVADOZ PHARMACEUTICALS LLC]",
      "spl_version": "1",
      "published_date": "2026-01-30"
    }
  },
  "productid": "59651-449_c220484e-1e6a-4a0c-a221-60223f3bc24c",
  "productndc": "59651-449",
  "dosage_form": "GRANULE",
  "orange_book": {
    "appl_no": "215137",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "90MG",
        "product_no": "001",
        "approval_date": "Sep 8, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "180MG",
        "product_no": "002",
        "approval_date": "Sep 8, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "360MG",
        "product_no": "003",
        "approval_date": "Sep 8, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEFERASIROX",
  "proprietary_name": "DEFERASIROX",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215137",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DEFERASIROX",
  "start_marketing_date": "20250908",
  "active_numerator_strength": "360"
}

Related drugs

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