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United States · US · US:70839-362_0fb0298f-9757-26e8-e063-6294a90ae8f2

COCAINE HYDROCHLORIDE

Orange BookUNIISPLATC N01BC01

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

Identification

ManufacturerLXO US INC.
CountryUS (United States)
ATC codeN01BC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7083936204
    1 BOTTLE, GLASS in 1 CARTON (70839-362-04) / 4 mL in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)
XH8T8T6WZH
COCAINE HYDROCHLORIDE
RxCUI 81985
Orange Book
N209963
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": "NASAL",
  "spl_meta": {
    "0fb0298f-9756-26e8-e063-6294a90ae8f2": {
      "match": "brand_token",
      "title": "COCAINE HYDROCHLORIDE SOLUTION [LXO US INC.]",
      "spl_version": "1",
      "published_date": "2024-01-29"
    }
  },
  "productid": "70839-362_0fb0298f-9757-26e8-e063-6294a90ae8f2",
  "productndc": "70839-362",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "209963",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4%",
        "product_no": "001",
        "approval_date": "Dec 14, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": "CII",
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "COCAINE HYDROCHLORIDE",
  "proprietary_name": "COCAINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA209963",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "COCAINE HYDROCHLORIDE",
  "start_marketing_date": "20240129",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code N01BC01.

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