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United States · US · US:81665-300_b722df62-ac8d-49c0-b357-c814b89471fe

NUMBRINO

Orange BookUNIISPLATC N01BC01

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

Identification

ManufacturerOMNIVIUM PHARMACEUTICALS LLC.
CountryUS (United States)
ATC codeN01BC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8166530002
    1 BOTTLE, GLASS in 1 CARTON (81665-300-02) / 4 mL in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)
XH8T8T6WZH
COCAINE HYDROCHLORIDE
RxCUI 81985
Orange Book
N209575
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "XH8T8T6WZH",
    "rxcui": "81985",
    "inchikey": "PIQVDUKEQYOJNR-VZXSFKIWSA-N",
    "display_name": "COCAINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "d724b5b4-6654-4bf5-9eed-e2c7943084ed": {
      "match": "brand_token",
      "title": "NUMBRINO (COCAINE HYDROCHLORIDE NASAL) SOLUTION [OMNIVIUM PHARMACEUTICALS LLC.]",
      "spl_version": "3",
      "published_date": "2026-01-19"
    }
  },
  "productid": "81665-300_b722df62-ac8d-49c0-b357-c814b89471fe",
  "productndc": "81665-300",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "209575",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4%",
        "product_no": "001",
        "approval_date": "Jan 10, 2020"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COCAINE HYDROCHLORIDE",
  "proprietary_name": "NUMBRINO",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA209575",
  "marketing_category": "NDA",
  "nonproprietary_name": "cocaine hydrochloride nasal",
  "start_marketing_date": "20240619",
  "active_numerator_strength": "40"
}

Related drugs

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