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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

  • ndc11
    1249600032
    2 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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