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United States · US · US:81033-021_4c0dce2f-a772-65cb-e063-6294a90a158e

prednisoLONE sodium phosphate

Orange BookUNIISPLATC S02BA03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerKesin Pharma
CountryUS (United States)
ATC codeS02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8103302154
    50 CUP, UNIT-DOSE in 1 CARTON (81033-021-54) / 5 mL in 1 CUP, UNIT-DOSE (81033-021-05)

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": "81033-021_4c0dce2f-a772-65cb-e063-6294a90a158e",
  "productndc": "81033-021",
  "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": "20231027",
  "active_numerator_strength": "15"
}

Related drugs

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