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United States · US · US:70515-701_fa248cfa-08c9-43a3-8289-a28e5447cb1d

Omnaris

Orange BookUNIIATC R03BA08

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

Identification

ManufacturerCovis Pharma US, Inc
CountryUS (United States)
ATC codeR03BA08
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7051570101
    1 POUCH in 1 CARTON (70515-701-01) / 1 BOTTLE, GLASS in 1 POUCH / 120 SPRAY in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)
S59502J185
CICLESONIDE
RxCUI 274964
Orange Book
N022004
Raw payload (JSON)
{
  "unii": {
    "unii": "S59502J185",
    "rxcui": "274964",
    "inchikey": "LUKZNWIVRBCLON-GXOBDPJESA-N",
    "display_name": "CICLESONIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "NASAL",
  "productid": "70515-701_fa248cfa-08c9-43a3-8289-a28e5447cb1d",
  "productndc": "70515-701",
  "dosage_form": "SPRAY",
  "orange_book": {
    "appl_no": "022004",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.05MG/SPRAY",
        "product_no": "001",
        "approval_date": "Oct 20, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CICLESONIDE",
  "proprietary_name": "Omnaris",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA022004",
  "marketing_category": "NDA",
  "nonproprietary_name": "ciclesonide",
  "start_marketing_date": "20180423",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code R03BA08.

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