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United States · US · US:70839-359_0f897764-fe31-090a-e063-6294a90af106
Goprelto
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
- ndc1170839359041 BOTTLE, GLASS in 1 CARTON (70839-359-04) / 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": {
"0f897764-fe30-090a-e063-6294a90af106": {
"match": "brand_token",
"title": "GOPRELTO (COCAINE HYDROCHLORIDE) SOLUTION [LXO US INC.]",
"spl_version": "1",
"published_date": "2024-11-07"
}
},
"productid": "70839-359_0f897764-fe31-090a-e063-6294a90af106",
"productndc": "70839-359",
"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": "Goprelto",
"active_ingred_unit": "mg/mL",
"application_number": "NDA209963",
"marketing_category": "NDA",
"nonproprietary_name": "cocaine hydrochloride",
"start_marketing_date": "20240209",
"active_numerator_strength": "40"
}Related drugs
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