Prednisolone Sodium Phosphate

Orange BookUNIISPLATC S02BA03

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

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 · 1

ndc11
0121475950
5 TRAY in 1 CASE (0121-4759-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4759-05)

Annotations

UNII (FDA Substance ID)

IV021NXA9J

PREDNISOLONE SODIUM PHOSPHATE

RxCUI 55062

Orange Book

A076913

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": "0121-4759_07592713-8b0b-47aa-8a7f-848823ff221c",
  "productndc": "0121-4759",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "076913",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 15MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Apr 25, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISOLONE SODIUM PHOSPHATE",
  "proprietary_name": "Prednisolone Sodium Phosphate",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA076913",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prednisolone Sodium Phosphate",
  "start_marketing_date": "20240322",
  "active_numerator_strength": "15"
}

Related drugs

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