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United States · US · US:62135-250_19febba3-956f-d1a9-e063-6394a90afda5

Prednisolone

Orange BookUNIISPLATC S02BA03

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

Identification

ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeS02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6213525024
    2 TRAY in 1 BOX (62135-250-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-250-45)
  • ndc11
    6213525037
    240 mL in 1 BOTTLE (62135-250-37)
  • ndc11
    6213525047
    480 mL in 1 BOTTLE (62135-250-47)

Annotations

UNII (FDA Substance ID)
9PHQ9Y1OLM
PREDNISOLONE
RxCUI 8638
Orange Book
A040323
AA
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": "62135-250_19febba3-956f-d1a9-e063-6394a90afda5",
  "productndc": "62135-250",
  "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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