opvee

Generic: nalmefene hydrochloride

Labeler: indivior inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name opvee
Generic Name nalmefene hydrochloride
Labeler indivior inc.
Dosage Form SPRAY
Routes
NASAL
Active Ingredients

nalmefene hydrochloride 2.7 mg/100uL

Manufacturer
Indivior Inc.

Identifiers & Regulatory

Product NDC 12496-0003
Product ID 12496-0003_47e34536-62c2-9ceb-e063-6294a90a57be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217470
Listing Expiration 2027-12-31
Marketing Start 2023-10-02

Pharmacologic Class

Classes
opioid antagonist [epc] opioid antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 124960003
Hyphenated Format 12496-0003

Supplemental Identifiers

RxCUI
2639721 2639727
UNII
K7K69QC05X

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name opvee (source: ndc)
Generic Name nalmefene hydrochloride (source: ndc)
Application Number NDA217470 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 2.7 mg/100uL
source: ndc
Packaging
  • 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
source: ndc

Packages (1)

12496-0003-2 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

Ingredients (1)

nalmefene hydrochloride (2.7 mg/100uL)

Linked Drug Pages (1)

OPVEE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "47e34536-62c2-9ceb-e063-6294a90a57be", "openfda": {"unii": ["K7K69QC05X"], "rxcui": ["2639721", "2639727"], "spl_set_id": ["999a4269-9e54-4801-b2ac-2a7276f0b94f"], "manufacturer_name": ["Indivior Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "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", "package_ndc": "12496-0003-2", "marketing_start_date": "20231002"}], "brand_name": "OPVEE", "product_id": "12496-0003_47e34536-62c2-9ceb-e063-6294a90a57be", "dosage_form": "SPRAY", "pharm_class": ["Opioid Antagonist [EPC]", "Opioid Antagonists [MoA]"], "product_ndc": "12496-0003", "generic_name": "nalmefene hydrochloride", "labeler_name": "Indivior Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OPVEE", "active_ingredients": [{"name": "NALMEFENE HYDROCHLORIDE", "strength": "2.7 mg/100uL"}], "application_number": "NDA217470", "marketing_category": "NDA", "marketing_start_date": "20231002", "listing_expiration_date": "20271231"}