Prednisolone

Orange BookUNIISPLATC S02BA03

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

Identification

ManufacturerChartwell Governmental & Specialty RX, LLC.

CountryUS (United States)

ATC codeS02BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6899925024
2 TRAY in 1 BOX (68999-250-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-250-45)

Annotations

UNII (FDA Substance ID)

9PHQ9Y1OLM

PREDNISOLONE

RxCUI 8638

Orange Book

A040323

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": "68999-250_43e3bba6-a836-f5e7-e063-6294a90a10e4",
  "productndc": "68999-250",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "040323",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "15MG/5ML",
        "product_no": "001",
        "approval_date": "May 13, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISOLONE",
  "proprietary_name": "Prednisolone",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA040323",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prednisolone oral",
  "start_marketing_date": "20221120",
  "active_numerator_strength": "15"
}

Related drugs

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