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United States · US · US:67877-554_5e8c386f-5879-4f68-bc6f-38041072f5ad

Deferasirox

Orange BookUNIISPLATC V03AC03

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

Identification

ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeV03AC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6787755430
    30 TABLET, FILM COATED in 1 BOTTLE (67877-554-30)
  • ndc11
    6787755490
    90 TABLET, FILM COATED in 1 BOTTLE (67877-554-90)

Annotations

UNII (FDA Substance ID)
V8G4MOF2V9
DEFERASIROX
RxCUI 614373
Orange Book
A210555
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": "67877-554_5e8c386f-5879-4f68-bc6f-38041072f5ad",
  "productndc": "67877-554",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210555",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "90MG",
        "product_no": "001",
        "approval_date": "Mar 30, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "360MG",
        "product_no": "002",
        "approval_date": "Mar 30, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "180MG",
        "product_no": "003",
        "approval_date": "Jul 2, 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": "ANDA210555",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Deferasirox",
  "start_marketing_date": "20200401",
  "active_numerator_strength": "360"
}

Related drugs

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