Depo-Medrol

In shortageOrange BookUNIISPLATC H02BX01

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeH02BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7642008101
1 mL in 1 VIAL, SINGLE-DOSE (76420-081-01)

Annotations

UNII (FDA Substance ID)

43502P7F0P

METHYLPREDNISOLONE ACETATE

RxCUI 155323

Orange Book

N011757

ABAB

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Methylprednisolone Acetate Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "43502P7F0P",
    "rxcui": "155323",
    "inchikey": "PLBHSZGDDKCEHR-LFYFAGGJSA-N",
    "display_name": "METHYLPREDNISOLONE ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRA-ARTICULAR; INTRALESIONAL; INTRAMUSCULAR; SOFT TISSUE",
  "spl_meta": {
    "9f1b7ce6-0733-47fa-8a14-a29a4d026992": {
      "match": "brand_token",
      "title": "DEPO-MEDROL (METHYLPREDNISOLONE ACETATE) INJECTION, SUSPENSION [ZOETIS INC.]",
      "spl_version": "6",
      "published_date": "2026-03-30"
    }
  },
  "productid": "76420-081_ead30b86-564f-7e78-e053-2a95a90ab41c",
  "productndc": "76420-081",
  "dosage_form": "INJECTION, SUSPENSION",
  "orange_book": {
    "appl_no": "011757",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "40MG/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "20MG/ML",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "80MG/ML",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLPREDNISOLONE ACETATE",
  "shortage_reason": "Methylprednisolone Acetate Injection",
  "shortage_status": "current",
  "proprietary_name": "Depo-Medrol",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA011757",
  "marketing_category": "NDA",
  "nonproprietary_name": "methylprednisolone acetate",
  "start_marketing_date": "19590528",
  "active_numerator_strength": "80"
}

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