ASMANEX HFA

Orange BookUNIISPLATC D07AC13

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerOrganon LLC

CountryUS (United States)

ATC codeD07AC13

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
7820611301
1 CANISTER in 1 CARTON (78206-113-01) / 120 AEROSOL in 1 CANISTER
ndc11
7820611359
1 CANISTER in 1 CARTON (78206-113-59) / 120 AEROSOL in 1 CANISTER

Annotations

UNII (FDA Substance ID)

04201GDN4R

MOMETASONE FUROATE

RxCUI 30145

Orange Book

N205641

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": "78206-113_75a83fa4-9a71-4e19-bcff-20dcd0101980",
  "productndc": "78206-113",
  "dosage_form": "AEROSOL",
  "orange_book": {
    "appl_no": "205641",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.10MG/INH",
        "product_no": "001",
        "approval_date": "Apr 25, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.20MG/INH",
        "product_no": "002",
        "approval_date": "Apr 25, 2014"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.05MG/INH",
        "product_no": "003",
        "approval_date": "Aug 12, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MOMETASONE FUROATE",
  "proprietary_name": "ASMANEX HFA",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA205641",
  "marketing_category": "NDA",
  "nonproprietary_name": "MOMETASONE FUROATE",
  "start_marketing_date": "20210601",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code D07AC13.

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