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United States · US · US:59651-402_b24f80c5-afe2-4821-9185-2dad3cfe277a

MOMETASONE FUROATE MONOHYDRATE

Orange BookUNIISPLATC D07AC13

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeD07AC13
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5965140217
    1 BOTTLE, SPRAY in 1 CARTON (59651-402-17) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY

Annotations

UNII (FDA Substance ID)
MTW0WEG809
MOMETASONE FUROATE MONOHYDRATE
RxCUI 153374
Orange Book
A215878
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "MTW0WEG809",
    "rxcui": "153374",
    "inchikey": "AQCCVUHZMIMSIB-HRVPQZBTSA-N",
    "display_name": "MOMETASONE FUROATE MONOHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "NASAL",
  "spl_meta": {
    "5eda1256-001a-4f40-b3ca-15349d532033": {
      "match": "brand_token",
      "title": "MOMETASONE FUROATE OINTMENT [BRYANT RANCH PREPACK]",
      "spl_version": "101",
      "published_date": "2026-05-25"
    }
  },
  "productid": "59651-402_b24f80c5-afe2-4821-9185-2dad3cfe277a",
  "productndc": "59651-402",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "215878",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.05MG/SPRAY",
        "product_no": "001",
        "approval_date": "Mar 18, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MOMETASONE FUROATE MONOHYDRATE",
  "proprietary_name": "MOMETASONE FUROATE MONOHYDRATE",
  "active_ingred_unit": "ug/1",
  "application_number": "ANDA215878",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MOMETASONE FUROATE MONOHYDRATE",
  "start_marketing_date": "20240318",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code D07AC13.

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