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United States · US · US:25021-820_13e1ca54-4fc4-4e93-a52d-c9320865e3cb

methylprednisolone acetate

In shortageOrange BookUNIISPLATC H02BX01

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

Identification

ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeH02BX01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    2502182005
    1 VIAL in 1 CARTON (25021-820-05) / 5 mL in 1 VIAL
  • ndc11
    2502182010
    1 VIAL in 1 CARTON (25021-820-10) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
43502P7F0P
METHYLPREDNISOLONE ACETATE
RxCUI 155323
Orange Book
A201835
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; INTRASYNOVIAL; 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": "25021-820_13e1ca54-4fc4-4e93-a52d-c9320865e3cb",
  "productndc": "25021-820",
  "dosage_form": "INJECTION, SUSPENSION",
  "orange_book": {
    "appl_no": "201835",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG/ML",
        "product_no": "001",
        "approval_date": "Jun 27, 2018"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG/ML",
        "product_no": "002",
        "approval_date": "Jun 27, 2018"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "80MG/ML",
        "product_no": "003",
        "approval_date": "Jun 27, 2018"
      }
    ],
    "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": "ANDA201835",
  "marketing_category": "ANDA",
  "nonproprietary_name": "methylprednisolone acetate",
  "start_marketing_date": "20211115",
  "active_numerator_strength": "40"
}

Related drugs

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