Solu-Cortef

Orange BookUNIISPLATC A07EA02

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

Identification

ManufacturerProPharma Distribution

CountryUS (United States)

ATC codeA07EA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8454901104
2 mL in 1 VIAL, SINGLE-DOSE (84549-011-04)

Annotations

UNII (FDA Substance ID)

50LQB69S1Z

HYDROCORTISONE SODIUM SUCCINATE

RxCUI 235483

Orange Book

N009866

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "50LQB69S1Z",
    "rxcui": "235483",
    "inchikey": "HHZQLQREDATOBM-CODXZCKSSA-M",
    "display_name": "HYDROCORTISONE SODIUM SUCCINATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "65eefd58-b166-4d71-ade6-45c8fdf86922": {
      "match": "brand_token",
      "title": "SOLU-CORTEF (HYDROCORTISONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]",
      "spl_version": "29",
      "published_date": "2025-09-10"
    }
  },
  "productid": "84549-011_3a38d1c4-e75c-f6e9-e063-6394a90a888b",
  "productndc": "84549-011",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "009866",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 100MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 250MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "HYDROCORTISONE SODIUM SUCCINATE",
  "proprietary_name": "Solu-Cortef",
  "active_ingred_unit": "mg/2mL",
  "application_number": "NDA009866",
  "marketing_category": "NDA",
  "nonproprietary_name": "hydrocortisone sodium succinate",
  "start_marketing_date": "19550427",
  "active_numerator_strength": "100"
}

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