PREDNISOLONE ACETATE

Orange BookUNIISPLATC S02BA03

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeS02BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009075390
1 BOTTLE in 1 CARTON (50090-7539-0) / 5 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

8B2807733D

PREDNISOLONE ACETATE

RxCUI 34372

Orange Book

A216935

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "8B2807733D",
    "rxcui": "34372",
    "inchikey": "LRJOMUJRLNCICJ-JZYPGELDSA-N",
    "display_name": "PREDNISOLONE ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "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": "50090-7539_af502300-c29e-405b-bb6f-f125d432a2c1",
  "productndc": "50090-7539",
  "dosage_form": "SUSPENSION/ DROPS",
  "orange_book": {
    "appl_no": "216935",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Aug 2, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISOLONE ACETATE",
  "proprietary_name": "PREDNISOLONE ACETATE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA216935",
  "marketing_category": "ANDA",
  "nonproprietary_name": "prednisolone acetate",
  "start_marketing_date": "20241011",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code S02BA03.

Access this data programmatically

Query PREDNISOLONE ACETATE 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