Methylprednisolone Acetate

In shortageOrange BookUNIISPLATC H02BX01

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

Identification

ManufacturerCaplin Steriles Limited

CountryUS (United States)

ATC codeH02BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6514519325
25 VIAL, SINGLE-DOSE in 1 CARTON (65145-193-25) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-193-01)

Annotations

UNII (FDA Substance ID)

43502P7F0P

METHYLPREDNISOLONE ACETATE

RxCUI 155323

Orange Book

A220556

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": {
    "7092df48-4904-4047-9916-e585417a216f": {
      "match": "brand_token",
      "title": "METHYLPREDNISOLONE TABLET [BLUEPOINT LABORATORIES]",
      "spl_version": "3",
      "published_date": "2026-05-25"
    }
  },
  "productid": "65145-193_23f98766-7571-49cb-8c1a-58fabba53965",
  "productndc": "65145-193",
  "dosage_form": "INJECTION, SUSPENSION",
  "orange_book": {
    "appl_no": "220556",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG/ML",
        "product_no": "001",
        "approval_date": "Jan 26, 2026"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG/ML",
        "product_no": "002",
        "approval_date": "Jan 26, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLPREDNISOLONE ACETATE",
  "shortage_reason": "Methylprednisolone Acetate Injection",
  "shortage_status": "current",
  "proprietary_name": "Methylprednisolone Acetate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA220556",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Methylprednisolone Acetate",
  "start_marketing_date": "20260206",
  "active_numerator_strength": "80"
}

Related drugs

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