KYMBEE

Orange BookUNIISPLATC H02AB13

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

Identification

ManufacturerUpsher-Smith Laboratories, LLC

CountryUS (United States)

ATC codeH02AB13

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0245081730
1 BOTTLE in 1 CARTON (0245-0817-30) / 30 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

KR5YZ6AE4B

DEFLAZACORT

RxCUI 22396

Orange Book

A216720

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": {
    "89365f9f-a7ae-40d3-aecc-e4add75d21c2": {
      "match": "brand_token",
      "title": "KYMBEE (DEFLAZACORT) TABLET [UPSHER-SMITH LABORATORIES, LLC]",
      "spl_version": "1",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0245-0817_36f2e4f6-17ab-498c-882b-c51a45c97893",
  "productndc": "0245-0817",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216720",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "6MG",
        "product_no": "001",
        "approval_date": "Nov 5, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "18MG",
        "product_no": "002",
        "approval_date": "Nov 5, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "003",
        "approval_date": "Nov 5, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "36MG",
        "product_no": "004",
        "approval_date": "Nov 5, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEFLAZACORT",
  "proprietary_name": "KYMBEE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216720",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Deflazacort",
  "start_marketing_date": "20241105",
  "active_numerator_strength": "36"
}

Related drugs

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