PREDNISOLONE

Orange BookUNIISPLATC S02BA03

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

Identification

ManufacturerHisun Pharmaceuticals USA, Inc.

CountryUS (United States)

ATC codeS02BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4265816005
100 TABLET in 1 BOTTLE (42658-160-05)

Annotations

UNII (FDA Substance ID)

9PHQ9Y1OLM

PREDNISOLONE

RxCUI 8638

Orange Book

A218083

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "9PHQ9Y1OLM",
    "rxcui": "8638",
    "inchikey": "OIGNJSKKLXVSLS-VWUMJDOOSA-N",
    "display_name": "PREDNISOLONE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "02fc6f0b-d053-49e1-82de-f272dd05d529": {
      "match": "brand_token",
      "title": "PREDNISOLONE ACETATE SUSPENSION/ DROPS [SPORTPHARM LLC]",
      "spl_version": "2",
      "published_date": "2026-04-27"
    }
  },
  "productid": "42658-160_9f93400d-a8c0-435a-ad65-48717cc455cf",
  "productndc": "42658-160",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "218083",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "May 2, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISOLONE",
  "proprietary_name": "PREDNISOLONE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA218083",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PREDNISOLONE",
  "start_marketing_date": "20240901",
  "active_numerator_strength": "5"
}

Related drugs

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