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United States · US · US:0135-0615_85fd731d-433f-4eba-aad8-6eda4550138e

FLONASE SENSIMIST

In shortageOrange BookUNIISPLATC R01AD12

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

Identification

ManufacturerHaleon US Holdings LLC
CountryUS (United States)
ATC codeR01AD12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    0135061501
    1 BOTTLE in 1 CARTON (0135-0615-01) / 30 SPRAY, METERED in 1 BOTTLE
  • ndc11
    0135061502
    1 BOTTLE in 1 PACKAGE (0135-0615-02) / 60 SPRAY, METERED in 1 BOTTLE
  • ndc11
    0135061503
    1 BOTTLE in 1 PACKAGE (0135-0615-03) / 120 SPRAY, METERED in 1 BOTTLE
  • ndc11
    0135061504
    3 BOTTLE in 1 PACKAGE (0135-0615-04) / 120 SPRAY, METERED in 1 BOTTLE
  • ndc11
    0135061505
    2 BOTTLE in 1 PACKAGE (0135-0615-05) / 120 SPRAY, METERED in 1 BOTTLE
  • ndc11
    0135061506
    1 BOTTLE in 1 PACKAGE (0135-0615-06) / 72 SPRAY, METERED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
JS86977WNV
FLUTICASONE FUROATE
RxCUI 705022
Orange Book
N022051
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Fluticasone Propionate; Salmeterol Xinafoate Powder
Raw payload (JSON)
{
  "unii": {
    "unii": "JS86977WNV",
    "rxcui": "705022",
    "inchikey": "XTULMSXFIHGYFS-VLSRWLAYSA-N",
    "display_name": "FLUTICASONE FUROATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "NASAL",
  "spl_meta": {
    "b6134ba0-b70a-4eac-9a82-cef64b242c1d": {
      "match": "brand_token",
      "title": "FLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) SPRAY, METERED [HALEON US HOLDINGS LLC]",
      "spl_version": "21",
      "published_date": "2024-12-23"
    }
  },
  "productid": "0135-0615_85fd731d-433f-4eba-aad8-6eda4550138e",
  "productndc": "0135-0615",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "022051",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.0275MG/SPRAY",
        "product_no": "002",
        "approval_date": "Aug 2, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FLUTICASONE FUROATE",
  "shortage_reason": "Fluticasone Propionate; Salmeterol Xinafoate Powder",
  "shortage_status": "current",
  "proprietary_name": "FLONASE SENSIMIST",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA022051",
  "marketing_category": "NDA",
  "nonproprietary_name": "fluticasone furoate",
  "start_marketing_date": "20170201",
  "active_numerator_strength": "27.5"
}

Related drugs

Other records sharing ATC code R01AD12.

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