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United States · US · US:12496-0003_47e34536-62c2-9ceb-e063-6294a90a57be
OPVEE
Orange BookUNIISPLATC N07BB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIndivior Inc.
CountryUS (United States)
ATC codeN07BB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1112496000322 BLISTER PACK in 1 CARTON (12496-0003-2) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (12496-0003-1) / 100 uL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
K7K69QC05X
NALMEFENE HYDROCHLORIDE
RxCUI 236069
Orange Book
N217470
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "K7K69QC05X",
"rxcui": "236069",
"inchikey": "GYWMRGWFQPSQLK-OPHZJPRHSA-N",
"display_name": "NALMEFENE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "NASAL",
"spl_meta": {
"999a4269-9e54-4801-b2ac-2a7276f0b94f": {
"match": "brand_token",
"title": "OPVEE (NALMEFENE HYDROCHLORIDE) SPRAY [INDIVIOR INC.]",
"spl_version": "8",
"published_date": "2026-01-09"
}
},
"productid": "12496-0003_47e34536-62c2-9ceb-e063-6294a90a57be",
"productndc": "12496-0003",
"dosage_form": "SPRAY",
"orange_book": {
"appl_no": "217470",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 2.7MG BASE/SPRAY",
"product_no": "001",
"approval_date": "May 22, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NALMEFENE HYDROCHLORIDE",
"proprietary_name": "OPVEE",
"active_ingred_unit": "mg/100uL",
"application_number": "NDA217470",
"marketing_category": "NDA",
"nonproprietary_name": "nalmefene hydrochloride",
"start_marketing_date": "20231002",
"active_numerator_strength": "2.7"
}Related drugs
Other records sharing ATC code N07BB05.
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