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United States · US · US:73190-070_459b75af-2b59-2f1e-e063-6394a90a9ed4

Deflazacort

Orange BookUNIISPLATC H02AB13

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

Identification

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

Packs · 1

  • ndc11
    7319007030
    1 BOTTLE in 1 CARTON (73190-070-30) / 30 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
KR5YZ6AE4B
DEFLAZACORT
RxCUI 22396
Orange Book
A219254
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": "73190-070_459b75af-2b59-2f1e-e063-6394a90a9ed4",
  "productndc": "73190-070",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "219254",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "6MG",
        "product_no": "001",
        "approval_date": "Apr 8, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "18MG",
        "product_no": "002",
        "approval_date": "Apr 8, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "003",
        "approval_date": "Apr 8, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "36MG",
        "product_no": "004",
        "approval_date": "Apr 8, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEFLAZACORT",
  "proprietary_name": "Deflazacort",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA219254",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Deflazacort",
  "start_marketing_date": "20251210",
  "active_numerator_strength": "30"
}

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