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United States · US · US:36800-222_343d4087-6c6d-430a-a927-d1c0cedf420e

topcare fluticasone propionate nasal

In shortageOrange BookUNIISPLATC D07AC17

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

Identification

ManufacturerTopco Associates LLC
CountryUS (United States)
ATC codeD07AC17
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    3680022201
    1 BOTTLE in 1 CARTON (36800-222-01) / 120 SPRAY, METERED in 1 BOTTLE
  • ndc11
    3680022203
    2 BOTTLE in 1 CARTON (36800-222-03) / 120 SPRAY, METERED in 1 BOTTLE
  • ndc11
    3680022209
    1 BOTTLE in 1 CARTON (36800-222-09) / 144 SPRAY, METERED in 1 BOTTLE
  • ndc11
    3680022210
    2 BOTTLE in 1 CARTON (36800-222-10) / 144 SPRAY, METERED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
O2GMZ0LF5W
FLUTICASONE PROPIONATE
RxCUI 50121
Orange Book
A207957
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Fluticasone Propionate; Salmeterol Xinafoate Powder
Raw payload (JSON)
{
  "unii": {
    "unii": "O2GMZ0LF5W",
    "rxcui": "50121",
    "inchikey": "WMWTYOKRWGGJOA-CENSZEJFSA-N",
    "display_name": "FLUTICASONE PROPIONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "NASAL",
  "spl_meta": {
    "a88e5b8e-e6dd-4a1c-9628-5861d3205bdb": {
      "match": "brand_token",
      "title": "TOPCARE DAY TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [TOPCO ASSOCIATES LLC]",
      "spl_version": "10",
      "published_date": "2026-06-01"
    }
  },
  "productid": "36800-222_343d4087-6c6d-430a-a927-d1c0cedf420e",
  "productndc": "36800-222",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "207957",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "0.05MG/SPRAY",
        "product_no": "001",
        "approval_date": "May 26, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FLUTICASONE PROPIONATE",
  "shortage_reason": "Fluticasone Propionate; Salmeterol Xinafoate Powder",
  "shortage_status": "current",
  "proprietary_name": "topcare fluticasone propionate nasal",
  "active_ingred_unit": "ug/1",
  "application_number": "ANDA207957",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluticasone propionate",
  "start_marketing_date": "20160624",
  "active_numerator_strength": "50"
}

Related drugs

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