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United States · US · US:46708-324_3b7b2b3c-507c-4ea9-a45d-f5e38f9e1b80

Deferasirox

Orange BookUNIISPLATC V03AC03

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

Identification

ManufacturerAlembic Pharmaceuticals Limited
CountryUS (United States)
ATC codeV03AC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4670832430
    30 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-324-30)

Annotations

UNII (FDA Substance ID)
V8G4MOF2V9
DEFERASIROX
RxCUI 614373
Orange Book
A210060
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": "46708-324_3b7b2b3c-507c-4ea9-a45d-f5e38f9e1b80",
  "productndc": "46708-324",
  "dosage_form": "TABLET, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "210060",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG",
        "product_no": "001",
        "approval_date": "Nov 20, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "002",
        "approval_date": "Nov 20, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "003",
        "approval_date": "Nov 20, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEFERASIROX",
  "proprietary_name": "Deferasirox",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210060",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Deferasirox",
  "start_marketing_date": "20191121",
  "active_numerator_strength": "125"
}

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