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United States · US · US:81806-200_40a833b9-1c02-ffe2-e063-6294a90aac4e

Deflazacort Oral Suspension

Orange BookUNIISPLATC H02AB13

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

Identification

ManufacturerDoppel Farmaceutici S.r.l.
CountryUS (United States)
ATC codeH02AB13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8180620073
    1 BOTTLE in 1 CARTON (81806-200-73) / 13 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
KR5YZ6AE4B
DEFLAZACORT
RxCUI 22396
Orange Book
A220042
AB
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": "81806-200_40a833b9-1c02-ffe2-e063-6294a90aac4e",
  "productndc": "81806-200",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "220042",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "22.75MG/ML",
        "product_no": "001",
        "approval_date": "Oct 3, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEFLAZACORT",
  "proprietary_name": "Deflazacort Oral Suspension",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA220042",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Deflazacort",
  "start_marketing_date": "20251023",
  "active_numerator_strength": "22.75"
}

Related drugs

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