prednisolone acetate

Orange BookUNIISPLATC S02BA03

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

Identification

ManufacturerAmneal Pharmaceuticals NY LLC

CountryUS (United States)

ATC codeS02BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6021925521
1 BOTTLE, PLASTIC in 1 CARTON (60219-2552-1) / 15 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)

8B2807733D

PREDNISOLONE ACETATE

RxCUI 34372

Orange Book

A218256

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": "60219-2552_b184f928-3c7a-46a0-9c67-7d2946a37868",
  "productndc": "60219-2552",
  "dosage_form": "SUSPENSION/ DROPS",
  "orange_book": {
    "appl_no": "218256",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Jun 11, 2025"
      }
    ],
    "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": "ANDA218256",
  "marketing_category": "ANDA",
  "nonproprietary_name": "prednisolone acetate",
  "start_marketing_date": "20250613",
  "active_numerator_strength": "10"
}

Related drugs

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