Prednisolone Acetate

Orange BookUNIISPLATC S02BA03

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

Identification

ManufacturerSandoz Inc

CountryUS (United States)

ATC codeS02BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6131463705
1 BOTTLE, PLASTIC in 1 CARTON (61314-637-05) / 5 mL in 1 BOTTLE, PLASTIC
ndc11
6131463710
1 BOTTLE, PLASTIC in 1 CARTON (61314-637-10) / 10 mL in 1 BOTTLE, PLASTIC
ndc11
6131463715
1 BOTTLE, PLASTIC in 1 CARTON (61314-637-15) / 15 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)

8B2807733D

PREDNISOLONE ACETATE

RxCUI 34372

Orange Book

N017469

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": "61314-637_32f12438-f75f-459e-a41f-34dcc8a9e4f7",
  "productndc": "61314-637",
  "dosage_form": "SUSPENSION/ DROPS",
  "orange_book": {
    "appl_no": "017469",
    "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": "NDA017469",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Prednisolone Acetate",
  "start_marketing_date": "19941215",
  "active_numerator_strength": "10"
}

Related drugs

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