Alkindi

Orange BookUNIISPLATC A07EA02

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

Identification

ManufacturerEton Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeA07EA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7186310950
1 BOTTLE, PLASTIC in 1 CARTON (71863-109-50) / 50 GRANULE in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)

WI4X0X7BPJ

HYDROCORTISONE

RxCUI 5492

Orange Book

N213876

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "WI4X0X7BPJ",
    "rxcui": "5492",
    "inchikey": "JYGXADMDTFJGBT-VWUMJDOOSA-N",
    "display_name": "HYDROCORTISONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "26c13a5f-7119-4c6a-bf10-fda4e07d7682": {
      "match": "brand_token",
      "title": "ALKINDI SPRINKLE (HYDROCORTISONE) GRANULE ALKINDI SPRINKLE (HYDROCORTISONE) GRANULE [ETON PHARMACEUTICALS, INC.]",
      "spl_version": "20",
      "published_date": "2026-04-28"
    }
  },
  "productid": "71863-109_4ffdccff-95d3-7c88-e063-6394a90a1c9f",
  "productndc": "71863-109",
  "dosage_form": "GRANULE",
  "orange_book": {
    "appl_no": "213876",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.5MG",
        "product_no": "001",
        "approval_date": "Sep 29, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "1MG",
        "product_no": "002",
        "approval_date": "Sep 29, 2020"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2MG",
        "product_no": "003",
        "approval_date": "Sep 29, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "004",
        "approval_date": "Sep 29, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCORTISONE",
  "proprietary_name": "Alkindi",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA213876",
  "marketing_category": "NDA",
  "nonproprietary_name": "Hydrocortisone",
  "start_marketing_date": "20200929",
  "active_numerator_strength": ".5"
}

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