Methylprednisolone Sodium Succinate

In shortageOrange BookUNIISPLATC H02BX01

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeH02BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332325503
25 VIAL, SINGLE-DOSE in 1 TRAY (63323-255-03) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-255-01)

Annotations

UNII (FDA Substance ID)

LEC9GKY20K

METHYLPREDNISOLONE SODIUM SUCCINATE

RxCUI 203189

Orange Book

A040583

APAP

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": {
    "7092df48-4904-4047-9916-e585417a216f": {
      "match": "brand_token",
      "title": "METHYLPREDNISOLONE TABLET [BLUEPOINT LABORATORIES]",
      "spl_version": "3",
      "published_date": "2026-05-25"
    }
  },
  "productid": "63323-255_dc369096-3042-4942-9aeb-bbdf98f35bb8",
  "productndc": "63323-255",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "040583",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 40MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Jul 30, 2004"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 125MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Jul 30, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLPREDNISOLONE SODIUM SUCCINATE",
  "shortage_reason": "Methylprednisolone Acetate Injection",
  "shortage_status": "current",
  "proprietary_name": "Methylprednisolone Sodium Succinate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA040583",
  "marketing_category": "ANDA",
  "nonproprietary_name": "METHYLPREDNISOLONE SODIUM SUCCINATE",
  "start_marketing_date": "20041130",
  "active_numerator_strength": "40"
}

Related drugs

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