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United States · US · US:0054-0576_85bc2162-59ea-409a-94c2-0edef74922f5

Deferiprone

In shortageOrange BookUNIISPLATC V03AC02

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeV03AC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0054057625
    100 TABLET, COATED in 1 BOTTLE (0054-0576-25)

Annotations

UNII (FDA Substance ID)
2BTY8KH53L
DEFERIPRONE
RxCUI 11645
Orange Book
A213239
ABAB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Deferiprone Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "2BTY8KH53L",
    "rxcui": "11645",
    "inchikey": "TZXKOCQBRNJULO-UHFFFAOYSA-N",
    "display_name": "DEFERIPRONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "67139215-1154-4e1a-ae15-0f3cd8af5177": {
      "match": "brand_token",
      "title": "DEFERIPRONE TABLET, COATED [DR. REDDY'S LABORATORIES, INC.]",
      "spl_version": "1",
      "published_date": "2025-12-16"
    }
  },
  "productid": "0054-0576_85bc2162-59ea-409a-94c2-0edef74922f5",
  "productndc": "0054-0576",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "213239",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "001",
        "approval_date": "Mar 29, 2021"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "1GM",
        "product_no": "002",
        "approval_date": "Feb 8, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEFERIPRONE",
  "shortage_reason": "Deferiprone Tablet",
  "shortage_status": "current",
  "proprietary_name": "Deferiprone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213239",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Deferiprone",
  "start_marketing_date": "20210603",
  "active_numerator_strength": "500"
}

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