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United States · US · US:59651-600_dc2886e0-4e19-4a7c-b7ae-5723d7b4b8c9

Deflazacort

Orange BookUNIISPLATC H02AB13

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeH02AB13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5965160030
    30 TABLET in 1 BOTTLE (59651-600-30)

Annotations

UNII (FDA Substance ID)
KR5YZ6AE4B
DEFLAZACORT
RxCUI 22396
Orange Book
A217123
ABABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "KR5YZ6AE4B",
    "rxcui": "22396",
    "inchikey": "FBHSPRKOSMHSIF-GRMWVWQJSA-N",
    "display_name": "DEFLAZACORT",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2fac1332-0247-1047-e063-6294a90a557f": {
      "match": "brand_token",
      "title": "DEFLAZACORT ORAL SUSPENSION (DEFLAZACORT ORAL) SUSPENSION [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "2",
      "published_date": "2026-02-02"
    }
  },
  "productid": "59651-600_dc2886e0-4e19-4a7c-b7ae-5723d7b4b8c9",
  "productndc": "59651-600",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "217123",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "6MG",
        "product_no": "001",
        "approval_date": "Feb 9, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "18MG",
        "product_no": "002",
        "approval_date": "Feb 9, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "003",
        "approval_date": "Feb 9, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "36MG",
        "product_no": "004",
        "approval_date": "Feb 9, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEFLAZACORT",
  "proprietary_name": "Deflazacort",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217123",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Deflazacort",
  "start_marketing_date": "20240209",
  "active_numerator_strength": "18"
}

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