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United States · US · US:69292-722_1ec17137-cc34-44e9-b03f-efcafeb0fe05

Flurbiprofen Sodium

Orange BookUNIISPLATC M02AA19

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

Identification

ManufacturerAmici Pharma, Inc.
CountryUS (United States)
ATC codeM02AA19
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6929272225
    1 BOTTLE, DROPPER in 1 CARTON (69292-722-25) / 2.5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
Z5B97MU9K4
FLURBIPROFEN SODIUM
RxCUI 91351
Orange Book
A074447
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "Z5B97MU9K4",
    "rxcui": "91351",
    "inchikey": "GNMBMOULKUXEQF-UHFFFAOYSA-M",
    "display_name": "FLURBIPROFEN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "c27f2d57-4b9d-4b78-8d85-3bac84f733b1": {
      "match": "brand_token",
      "title": "FLURBIPROFEN SODIUM SOLUTION/ DROPS [AMICI PHARMA, INC.]",
      "spl_version": "6",
      "published_date": "2026-05-07"
    }
  },
  "productid": "69292-722_1ec17137-cc34-44e9-b03f-efcafeb0fe05",
  "productndc": "69292-722",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "074447",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "0.03%",
        "product_no": "001",
        "approval_date": "Jan 4, 1995"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLURBIPROFEN SODIUM",
  "proprietary_name": "Flurbiprofen Sodium",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA074447",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Flurbiprofen Sodium",
  "start_marketing_date": "20180331",
  "active_numerator_strength": ".3"
}

Related drugs

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