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United States · US · US:11980-180_bff1726c-7781-49de-8a61-bc37a755c92b

PRED FORTE

Orange BookUNIISPLATC S02BA03

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

Identification

ManufacturerAllergan, Inc.
CountryUS (United States)
ATC codeS02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    1198018005
    1 BOTTLE, DROPPER in 1 CARTON (11980-180-05) / 5 mL in 1 BOTTLE, DROPPER
  • ndc11
    1198018010
    1 BOTTLE, DROPPER in 1 CARTON (11980-180-10) / 10 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
8B2807733D
PREDNISOLONE ACETATE
RxCUI 34372
Orange Book
N017011
AB
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": {
    "4fcce64a-94ea-4031-ad5a-c4eddc73a910": {
      "match": "brand_token",
      "title": "PRED MILD (PREDNISOLONE ACETATE) SUSPENSION/ DROPS [ALLERGAN, INC.]",
      "spl_version": "16",
      "published_date": "2026-01-15"
    }
  },
  "productid": "11980-180_bff1726c-7781-49de-8a61-bc37a755c92b",
  "productndc": "11980-180",
  "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": "PRED FORTE",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA017011",
  "marketing_category": "NDA",
  "nonproprietary_name": "prednisolone acetate",
  "start_marketing_date": "19730601",
  "active_numerator_strength": "10"
}

Related drugs

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