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United States · US · US:0121-0885_1166b85b-73c5-4a8f-bc41-f99b406d0ff5

Prednisolone

Orange BookUNIISPLATC S02BA03

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

Identification

ManufacturerPAI Holdings, LLC dba PAI Pharma
CountryUS (United States)
ATC codeS02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0121088508
    240 mL in 1 BOTTLE (0121-0885-08)
  • ndc11
    0121088516
    480 mL in 1 BOTTLE (0121-0885-16)

Annotations

UNII (FDA Substance ID)
9PHQ9Y1OLM
PREDNISOLONE
RxCUI 8638
Orange Book
A040571
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": "0121-0885_1166b85b-73c5-4a8f-bc41-f99b406d0ff5",
  "productndc": "0121-0885",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "040571",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "15MG/5ML",
        "product_no": "001",
        "approval_date": "Aug 25, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISOLONE",
  "proprietary_name": "Prednisolone",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA040571",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prednisolone",
  "start_marketing_date": "20230912",
  "active_numerator_strength": "15"
}

Related drugs

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