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United States · US · US:45963-456_daefa0d6-0d5a-48fe-897b-cbc3e1db47f7

Deferasirox

Orange BookUNIISPLATC V03AC03

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

Identification

ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeV03AC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4596345630
    30 TABLET, FOR SUSPENSION in 1 BOTTLE (45963-456-30)

Annotations

UNII (FDA Substance ID)
V8G4MOF2V9
DEFERASIROX
RxCUI 614373
Orange Book
A203560
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": "45963-456_daefa0d6-0d5a-48fe-897b-cbc3e1db47f7",
  "productndc": "45963-456",
  "dosage_form": "TABLET, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "203560",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG",
        "product_no": "001",
        "approval_date": "Jan 26, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "Jan 26, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "003",
        "approval_date": "Jan 26, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEFERASIROX",
  "proprietary_name": "Deferasirox",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203560",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Deferasirox",
  "start_marketing_date": "20190322",
  "active_numerator_strength": "500"
}

Related drugs

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