Medrol

In shortageOrange BookUNIISPLATC H02BX01

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

Identification

ManufacturerPharmacia & Upjohn Company LLC

CountryUS (United States)

ATC codeH02BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0009002201
25 TABLET in 1 BOTTLE (0009-0022-01)

Annotations

UNII (FDA Substance ID)

X4W7ZR7023

METHYLPREDNISOLONE

RxCUI 6902

Orange Book

N011153

ABABABAB

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": {
    "39d5270b-d957-4821-93d6-501b7b9f02d4": {
      "match": "brand_token",
      "title": "MEDROL (METHYLPREDNISOLONE) TABLET [PHARMACIA & UPJOHN COMPANY LLC]",
      "spl_version": "25",
      "published_date": "2025-11-18"
    }
  },
  "productid": "0009-0022_e4a8e5b4-af77-4eca-92de-cd0982969b82",
  "productndc": "0009-0022",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "011153",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "16MG",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "24MG",
        "product_no": "005",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "32MG",
        "product_no": "006",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLPREDNISOLONE",
  "shortage_reason": "Methylprednisolone Acetate Injection",
  "shortage_status": "current",
  "proprietary_name": "Medrol",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA011153",
  "marketing_category": "NDA",
  "nonproprietary_name": "methylprednisolone",
  "start_marketing_date": "19571024",
  "active_numerator_strength": "8"
}

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