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
NDC Product Code12496-0003
Application NumberNDA217470
Marketing CategoryC73594
Route of AdministrationNASAL
Effective DateNovember 20, 2023
Generic Namenalmefene hydrochloride
INGREDIENTS (1)
nalmefene hydrochlorideActive
Quantity: 2.7 mg in 100 uL
Code: K7K69QC05X
Classification: ACTIM