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United States · US · US:55150-262_1d8c98fc-8bb8-4caa-a745-5d42ddd2c8ec

Methylprednisolone Sodium Succinate

In shortageOrange BookUNIISPLATC H02BX01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerEugia US LLC
CountryUS (United States)
ATC codeH02BX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5515026203
    25 VIAL, SINGLE-DOSE in 1 CARTON (55150-262-03) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
LEC9GKY20K
METHYLPREDNISOLONE SODIUM SUCCINATE
RxCUI 203189
Orange Book
A207667
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": "55150-262_1d8c98fc-8bb8-4caa-a745-5d42ddd2c8ec",
  "productndc": "55150-262",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "207667",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 40MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Dec 15, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 125MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Dec 15, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 500MG BASE/VIAL",
        "product_no": "003",
        "approval_date": "Dec 15, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2GM BASE/VIAL",
        "product_no": "004",
        "approval_date": "Dec 15, 2015"
      }
    ],
    "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/1",
  "application_number": "ANDA207667",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methylprednisolone Sodium Succinate",
  "start_marketing_date": "20151215",
  "active_numerator_strength": "40"
}

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