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United States · US · US:50742-317_139fb92c-bb10-4ee9-8572-679ac540aa27

Flunisolide

Orange BookUNIISPLATC R01AD04

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

Identification

ManufacturerIngenus Pharmaceuticals, LLC
CountryUS (United States)
ATC codeR01AD04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5074231725
    1 BOTTLE, PUMP in 1 CARTON (50742-317-25) / 25 mL in 1 BOTTLE, PUMP

Annotations

UNII (FDA Substance ID)
QK4DYS664X
FLUNISOLIDE
RxCUI 1298840
Orange Book
A207802
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "QK4DYS664X",
    "rxcui": "1298840",
    "inchikey": "MIXMJCQRHVAJIO-TZHJZOAOSA-N",
    "display_name": "FLUNISOLIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "NASAL",
  "spl_meta": {
    "7c72c954-3758-40c3-9977-d03b25d71e0a": {
      "match": "brand_token",
      "title": "FLUNISOLIDE SOLUTION [BAUSCH & LOMB INCORPORATED]",
      "spl_version": "19",
      "published_date": "2025-11-17"
    }
  },
  "productid": "50742-317_139fb92c-bb10-4ee9-8572-679ac540aa27",
  "productndc": "50742-317",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "207802",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.025MG/SPRAY",
        "product_no": "001",
        "approval_date": "Jun 16, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLUNISOLIDE",
  "proprietary_name": "Flunisolide",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA207802",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Flunisolide",
  "start_marketing_date": "20220623",
  "active_numerator_strength": ".25"
}

Related drugs

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