prednisolone sodium phosphate

Orange BookUNIISPLATC S02BA03

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

Identification

ManufacturerIngenus Pharmaceuticals, LLC

CountryUS (United States)

ATC codeS02BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5074238312
2 BLISTER PACK in 1 CARTON (50742-383-12) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50742-383-06)

Annotations

UNII (FDA Substance ID)

IV021NXA9J

PREDNISOLONE SODIUM PHOSPHATE

RxCUI 55062

Orange Book

N021959

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": "50742-383_ebbc1751-9381-4db1-89ff-ae5a2963fb2c",
  "productndc": "50742-383",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "021959",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Jun 1, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 15MG BASE",
        "product_no": "002",
        "approval_date": "Jun 1, 2006"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 30MG BASE",
        "product_no": "003",
        "approval_date": "Jun 1, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISOLONE SODIUM PHOSPHATE",
  "proprietary_name": "prednisolone sodium phosphate",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021959",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "prednisolone sodium phosphate",
  "start_marketing_date": "20250915",
  "active_numerator_strength": "10"
}

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