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United States · US · US:59467-700_84bec5d6-00c3-45a3-ae2b-ec28c8b9a290

Ryaltris

Orange BookUNIISPLATC D07AC

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

Identification

ManufacturerHIKMA SPECIALTY USA INC.
CountryUS (United States)
ATC codeD07AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5946770027
    12 CARTON in 1 BOX (59467-700-27) / 1 BOTTLE, SPRAY in 1 CARTON / 240 SPRAY, METERED in 1 BOTTLE, SPRAY
  • ndc11
    5946770084
    12 CARTON in 1 BOX (59467-700-84) / 1 BOTTLE, SPRAY in 1 CARTON / 56 SPRAY, METERED in 1 BOTTLE, SPRAY

Annotations

UNII (FDA Substance ID)
MTW0WEG809
MOMETASONE FUROATE MONOHYDRATE
RxCUI 153374
Orange Book
N211746
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": {
    "406be932-f00e-4c66-9dd1-c142090fe822": {
      "match": "brand_token",
      "title": "RYALTRIS (OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE) SPRAY, METERED [GLENMARK PHARMACEUTICALS INC., USA]",
      "spl_version": "1",
      "published_date": "2026-03-18"
    }
  },
  "productid": "59467-700_84bec5d6-00c3-45a3-ae2b-ec28c8b9a290",
  "productndc": "59467-700",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "211746",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.025MG/SPRAY;0.665MG/SPRAY",
        "product_no": "001",
        "approval_date": "Jan 13, 2022"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MOMETASONE FUROATE MONOHYDRATE; OLOPATADINE HYDROCHLORIDE",
  "proprietary_name": "Ryaltris",
  "active_ingred_unit": "ug/1; ug/1",
  "application_number": "NDA211746",
  "marketing_category": "NDA",
  "nonproprietary_name": "olopatadine hydrochloride and mometasone furoate",
  "start_marketing_date": "20220815",
  "active_numerator_strength": "25; 665"
}

Related drugs

Other records sharing ATC code D07AC.

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