JAYTHARI

Orange BookUNIISPLATC H02AB13

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

Identification

ManufacturerZydus Pharmaceuticals (USA) Inc.

CountryUS (United States)

ATC codeH02AB13

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7071017491
1 BOTTLE in 1 CARTON (70710-1749-1) / 100 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": {
    "abf1dba1-cfd8-4a05-aa2b-ffacfbeb9fa9": {
      "match": "brand_token",
      "title": "JAYTHARI ORAL SUSPENSION (DEFLAZACORT) SUSPENSION [ZYDUS PHARMACEUTICALS (USA) INC.]",
      "spl_version": "1",
      "published_date": "2025-11-21"
    }
  },
  "productid": "70710-1749_e23d418e-4806-48e4-8888-6ebfce3d907c",
  "productndc": "70710-1749",
  "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": "JAYTHARI",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA219254",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Deflazacort",
  "start_marketing_date": "20250612",
  "active_numerator_strength": "6"
}

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