Deferasirox

Orange BookUNIISPLATC V03AC03

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC

CountryUS (United States)

ATC codeV03AC03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6923814863
30 TABLET, FILM COATED in 1 BOTTLE (69238-1486-3)

Annotations

UNII (FDA Substance ID)

V8G4MOF2V9

DEFERASIROX

RxCUI 614373

Orange Book

A210727

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": "69238-1486_0b0b3d91-33d4-46b8-8bdc-fb9b5a9e99c7",
  "productndc": "69238-1486",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210727",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "90MG",
        "product_no": "001",
        "approval_date": "Dec 27, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "360MG",
        "product_no": "002",
        "approval_date": "Dec 27, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "180MG",
        "product_no": "003",
        "approval_date": "Jun 15, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEFERASIROX",
  "proprietary_name": "Deferasirox",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210727",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Deferasirox",
  "start_marketing_date": "20200102",
  "active_numerator_strength": "90"
}

Related drugs

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