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United States · US · US:55289-649_30c9fcb5-73bc-2f23-e063-6294a90a8ab4

MethylPREDNISolone

In shortageOrange BookUNIISPLATC H02BX01

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

Identification

ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeH02BX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5528964930
    30 TABLET in 1 BOTTLE, PLASTIC (55289-649-30)

Annotations

UNII (FDA Substance ID)
X4W7ZR7023
METHYLPREDNISOLONE
RxCUI 6902
Orange Book
A040183
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Methylprednisolone Acetate Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "X4W7ZR7023",
    "rxcui": "6902",
    "inchikey": "VHRSUDSXCMQTMA-PJHHCJLFSA-N",
    "display_name": "METHYLPREDNISOLONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "7092df48-4904-4047-9916-e585417a216f": {
      "match": "brand_token",
      "title": "METHYLPREDNISOLONE TABLET [BLUEPOINT LABORATORIES]",
      "spl_version": "3",
      "published_date": "2026-05-25"
    }
  },
  "productid": "55289-649_30c9fcb5-73bc-2f23-e063-6294a90a8ab4",
  "productndc": "55289-649",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040183",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Dec 22, 1998"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLPREDNISOLONE",
  "shortage_reason": "Methylprednisolone Acetate Injection",
  "shortage_status": "current",
  "proprietary_name": "MethylPREDNISolone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040183",
  "marketing_category": "ANDA",
  "nonproprietary_name": "methylprednisolone",
  "start_marketing_date": "19981222",
  "active_numerator_strength": "4"
}

Related drugs

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