Prednisolone Sodium Phosphate

Orange BookUNIISPLATC S02BA03

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

Identification

ManufacturerATLANTIC BIOLOGICALS CORP.

CountryUS (United States)

ATC codeS02BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
1785608151
72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0815-1) / 5 mL in 1 CUP, UNIT-DOSE
ndc11
1785608152
72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0815-2) / 10 mL in 1 CUP, UNIT-DOSE
ndc11
1785608153
48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0815-3) / 5 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)

IV021NXA9J

PREDNISOLONE SODIUM PHOSPHATE

RxCUI 55062

Orange Book

A203559

AAAAAAAA

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": "17856-0815_35cf03f4-200d-5643-e063-6394a90a9e02",
  "productndc": "17856-0815",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "203559",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 10MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Dec 20, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 20MG BASE/5ML",
        "product_no": "002",
        "approval_date": "Dec 20, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 15MG BASE/5ML",
        "product_no": "003",
        "approval_date": "Feb 6, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 25MG BASE/5ML",
        "product_no": "004",
        "approval_date": "Feb 6, 2023"
      }
    ],
    "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": "ANDA203559",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Prednisolone Sodium Phosphate",
  "start_marketing_date": "20231009",
  "active_numerator_strength": "15"
}

Related drugs

Other records sharing ATC code S02BA03.

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