OPVEE
These highlights do not include all the information needed to use OPVEE safely and effectively. See full prescribing information for OPVEE. OPVEE (nalmefene) nasal spray Initial U.S. Approval: 1995
Approved
Approval ID
999a4269-9e54-4801-b2ac-2a7276f0b94f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 20, 2023
Manufacturers
FDA
Indivior Inc.
DUNS: 797408549
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nalmefene hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code12496-0003
Application NumberNDA217470
Product Classification
M
Marketing Category
C73594
G
Generic Name
nalmefene hydrochloride
Product Specifications
Route of AdministrationNASAL
Effective DateNovember 20, 2023
FDA Product Classification
INGREDIENTS (1)
nalmefene hydrochlorideActive
Quantity: 2.7 mg in 100 uL
Code: K7K69QC05X
Classification: ACTIM