Prednisolone Sodium Phosphate Oral Solution

Orange BookUNIISPLATC S02BA03

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

Identification

ManufacturerBioComp Pharma, Inc.

CountryUS (United States)

ATC codeS02BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4452318208
237 mL in 1 BOTTLE (44523-182-08)

Annotations

UNII (FDA Substance ID)

IV021NXA9J

PREDNISOLONE SODIUM PHOSPHATE

RxCUI 55062

Orange Book

A091396

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "IV021NXA9J",
    "rxcui": "55062",
    "inchikey": "VJZLQIPZNBPASX-OJJGEMKLSA-L",
    "display_name": "PREDNISOLONE SODIUM PHOSPHATE",
    "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": "44523-182_450e8d3f-b6f6-5251-e063-6394a90aa439",
  "productndc": "44523-182",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "091396",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 25MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Sep 13, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISOLONE SODIUM PHOSPHATE",
  "proprietary_name": "Prednisolone Sodium Phosphate Oral Solution",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA091396",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prednisolone Sodium Phosphate",
  "start_marketing_date": "20191028",
  "active_numerator_strength": "25"
}

Related drugs

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