SOLU-MEDROL

In shortageOrange BookUNIISPLATC H02BX01

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

Identification

ManufacturerPharmacia & Upjohn Company LLC

CountryUS (United States)

ATC codeH02BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0009075801
1 VIAL in 1 CARTON (0009-0758-01) / 8 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

LEC9GKY20K

METHYLPREDNISOLONE SODIUM SUCCINATE

RxCUI 203189

Orange Book

N011856

APAPAPAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Methylprednisolone Acetate Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "LEC9GKY20K",
    "rxcui": "203189",
    "inchikey": "FQISKWAFAHGMGT-SGJOWKDISA-M",
    "display_name": "METHYLPREDNISOLONE SODIUM SUCCINATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "8e5997ed-f4a5-43f7-abbd-c8e2219fe0e9": {
      "match": "brand_token",
      "title": "SOLU-MEDROL (METHYLPREDNISOLONE SODIUM SUCCINATE) INJECTION, POWDER, FOR SOLUTION [A-S MEDICATION SOLUTIONS]",
      "spl_version": "33",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0009-0758_c157d266-8633-4c2e-ae1f-0207e4f19b35",
  "productndc": "0009-0758",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "011856",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 40MG BASE/VIAL",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 125MG BASE/VIAL",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "005",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 1GM BASE/VIAL",
        "product_no": "006",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 2GM BASE/VIAL",
        "product_no": "007",
        "approval_date": "Feb 27, 1985"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLPREDNISOLONE SODIUM SUCCINATE",
  "shortage_reason": "Methylprednisolone Acetate Injection",
  "shortage_status": "current",
  "proprietary_name": "SOLU-MEDROL",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA011856",
  "marketing_category": "NDA",
  "nonproprietary_name": "methylprednisolone sodium succinate",
  "start_marketing_date": "19590402",
  "active_numerator_strength": "500"
}

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