DEFLAZACORT

Orange BookUNIISPLATC H02AB13

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC

CountryUS (United States)

ATC codeH02AB13

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6021922851
1 BOTTLE in 1 CARTON (60219-2285-1) / 30 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

KR5YZ6AE4B

DEFLAZACORT

RxCUI 22396

Orange Book

A217173

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": "60219-2285_bf2296a0-7eb0-484f-b054-3d405c2c1dca",
  "productndc": "60219-2285",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "217173",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "6MG",
        "product_no": "001",
        "approval_date": "Dec 12, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "18MG",
        "product_no": "002",
        "approval_date": "Dec 12, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "003",
        "approval_date": "Dec 12, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "36MG",
        "product_no": "004",
        "approval_date": "Dec 12, 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": "ANDA217173",
  "marketing_category": "ANDA",
  "nonproprietary_name": "deflazacort",
  "start_marketing_date": "20251212",
  "active_numerator_strength": "36"
}

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