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
0121077708
237 mL in 1 BOTTLE (0121-0777-08)

Annotations

UNII (FDA Substance ID)

IV021NXA9J

PREDNISOLONE SODIUM PHOSPHATE

RxCUI 55062

Orange Book

A078988

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": "0121-0777_1b34fa45-5c3c-4a81-98be-0fbe2463c3d2",
  "productndc": "0121-0777",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "078988",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 20MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Jun 9, 2008"
      }
    ],
    "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": "ANDA078988",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prednisolone Sodium Phosphate",
  "start_marketing_date": "20170131",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code S02BA03.

Access this data programmatically

Query Prednisolone Sodium Phosphate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs