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United States · US · US:78206-114_4742e310-f27e-4c57-97d2-29034ed8bea8

ASMANEX

Orange BookUNIISPLATC D07AC13

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

Identification

ManufacturerOrganon LLC
CountryUS (United States)
ATC codeD07AC13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    7820611401
    1 POUCH in 1 CARTON (78206-114-01) / 1 INHALER in 1 POUCH / 120 INHALANT in 1 INHALER
  • ndc11
    7820611402
    1 POUCH in 1 CARTON (78206-114-02) / 1 INHALER in 1 POUCH / 60 INHALANT in 1 INHALER
  • ndc11
    7820611403
    1 POUCH in 1 CARTON (78206-114-03) / 1 INHALER in 1 POUCH / 14 INHALANT in 1 INHALER
  • ndc11
    7820611404
    1 POUCH in 1 CARTON (78206-114-04) / 1 INHALER in 1 POUCH / 30 INHALANT in 1 INHALER
  • ndc11
    7820611459
    1 POUCH in 1 CARTON (78206-114-59) / 1 INHALER in 1 POUCH / 14 INHALANT in 1 INHALER

Annotations

UNII (FDA Substance ID)
04201GDN4R
MOMETASONE FUROATE
RxCUI 30145
Orange Book
N021067
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "04201GDN4R",
    "rxcui": "30145",
    "inchikey": "WOFMFGQZHJDGCX-ZULDAHANSA-N",
    "display_name": "MOMETASONE FUROATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "0c6d63da-41bc-4894-bead-198e66c848ac": {
      "match": "brand_token",
      "title": "ASMANEX HFA (MOMETASONE FUROATE) AEROSOL [ORGANON LLC]",
      "spl_version": "7",
      "published_date": "2026-01-23"
    }
  },
  "productid": "78206-114_4742e310-f27e-4c57-97d2-29034ed8bea8",
  "productndc": "78206-114",
  "dosage_form": "INHALANT",
  "orange_book": {
    "appl_no": "021067",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.22MG/INH",
        "product_no": "001",
        "approval_date": "Mar 30, 2005"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.11MG/INH",
        "product_no": "002",
        "approval_date": "Feb 1, 2008"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MOMETASONE FUROATE",
  "proprietary_name": "ASMANEX",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA021067",
  "marketing_category": "NDA",
  "nonproprietary_name": "Mometasone Furoate",
  "start_marketing_date": "20210601",
  "active_numerator_strength": "220"
}

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