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United States · US · US:50090-3946_a30f8036-6f66-4ddd-9dfe-8b754d979099

Flurbiprofen Sodium

Orange BookUNIISPLATC M02AA19

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeM02AA19
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009039460
    1 BOTTLE, DROPPER in 1 CARTON (50090-3946-0) / 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": "50090-3946_a30f8036-6f66-4ddd-9dfe-8b754d979099",
  "productndc": "50090-3946",
  "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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