🇺🇸
United States · US · US:81665-301_4aa46865-9d43-4f88-b5d3-81200c6ec945
cocaine hydrochloride nasal
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
- ndc1181665301021 BOTTLE, GLASS in 1 CARTON (81665-301-02) / 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": {
"0fb0298f-9756-26e8-e063-6294a90ae8f2": {
"match": "brand_token",
"title": "COCAINE HYDROCHLORIDE SOLUTION [LXO US INC.]",
"spl_version": "1",
"published_date": "2024-01-29"
}
},
"productid": "81665-301_4aa46865-9d43-4f88-b5d3-81200c6ec945",
"productndc": "81665-301",
"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": "cocaine hydrochloride nasal",
"active_ingred_unit": "mg/mL",
"application_number": "NDA209575",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "cocaine hydrochloride nasal",
"start_marketing_date": "20231015",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code N01BC01.
- GBCocaine 10% eye drops preservative freeSpecial Order
- GBCocaine 10% mouthwashSpecial Order
- GBCocaine 10% nasal dropsSpecial Order
- GBCocaine 10% oromucosal pasteSpecial Order
- GBCocaine 10% solutionSpecial Order
- GBCocaine 10% sprayMartindale Pharmaceuticals Ltd
- GBCocaine 10% sprayAlliance Healthcare (Distribution) Ltd
- GBCocaine 10% sprayA A H Pharmaceuticals Ltd
Access this data programmatically
Query cocaine hydrochloride nasal and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.