Methylprednisolone Sodium Succinate

In shortageOrange BookUNIISPLATC H02BX01

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

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC codeH02BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7012110015
25 VIAL in 1 CARTON (70121-1001-5) / 2 mL in 1 VIAL (70121-1001-1)

Annotations

UNII (FDA Substance ID)

LEC9GKY20K

METHYLPREDNISOLONE SODIUM SUCCINATE

RxCUI 203189

Orange Book

A207549

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": "70121-1001_3eb27de6-9e1c-4ef4-bb31-2458b9360582",
  "productndc": "70121-1001",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "207549",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 40MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Nov 9, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 125MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Nov 9, 2016"
      }
    ],
    "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/2mL",
  "application_number": "ANDA207549",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methylprednisolone",
  "start_marketing_date": "20161111",
  "active_numerator_strength": "125"
}

Related drugs

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