PREDNISOLONE ACETATE

Orange BookUNIISPLATC S02BA03

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeS02BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7642020405
1 BOTTLE, DROPPER in 1 CARTON (76420-204-05) / 5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)

8B2807733D

PREDNISOLONE ACETATE

RxCUI 34372

Orange Book

N017011

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": "76420-204_d1fbb852-8bc5-7a0e-e053-2a95a90a2d8e",
  "productndc": "76420-204",
  "dosage_form": "SUSPENSION/ DROPS",
  "orange_book": {
    "appl_no": "017011",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PREDNISOLONE ACETATE",
  "proprietary_name": "PREDNISOLONE ACETATE",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA017011",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "prednisolone acetate",
  "start_marketing_date": "19970819",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code S02BA03.

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