SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINAT

In shortageOrange BookUNIISPLATC H02BX01

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst

CountryUS (United States)

ATC codeH02BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5166214831
1 VIAL in 1 CARTON (51662-1483-1) / 4 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": {
    "99b3c99a-79d5-6c54-e053-2a95a90a28bc": {
      "match": "brand_token",
      "title": "SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINAT INJECTION, POWDER, FOR SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]",
      "spl_version": "3",
      "published_date": "2025-01-10"
    }
  },
  "productid": "51662-1483_2b39b839-0c7c-de03-e063-6294a90a243e",
  "productndc": "51662-1483",
  "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(R) METHYLPREDNISOLONE SODIUM SUCCINAT",
  "active_ingred_unit": "mg/4mL",
  "application_number": "NDA011856",
  "marketing_category": "NDA",
  "nonproprietary_name": "SOLU-MEDROL(R) METHYLPREDNISOLONE SODIUM SUCCINAT",
  "start_marketing_date": "20191214",
  "active_numerator_strength": "500"
}

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