FDA.reportPublic FDA data

NDC 12496-0003-01 - OPVEE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
12496-0003
Requested NDC
12496-0003-01
Package NDCs from labels
12496-0003-1, 12496-0003-2, 12496-0003-01
Manufacturer
Indivior Inc.
Effective date
2026-01-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OPVEE - Indivior Inc.Indivior Inc.2026-01-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12496-0003-1OPVEE100 uL in 1 VIAL, SINGLE-DOSESPRAY1008
12496-0003-1OPVEE1 in 1 BLISTER PACKSPRAY18
12496-0003-2OPVEE2 in 1 CARTONSPRAY28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12496-0003OPVEE (NALMEFENE HYDROCHLORIDE) SPRAY [INDIVIOR INC.]6Current NDC, 3 package rows20241114_999a4269-9e54-4801-b2ac-2a7276f0b94f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12496-0003-1EA - Each12496-00036a027088-a101-4715-8c9a-8381a64f577312023-09-05
12496-0003-2EA - Each12496-0003752659b3-3b15-4045-9c62-912e31276bfe12023-09-05

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZurnaiNALMEFENE HYDROCHLORIDEKnoa Pharma LLCa59a5847-9fe4-4341-a203-be0a5e6d3e362026-07-31Warnings, Adverse reactionsExact identifier
unii: K7K69QC05X
NALMEFENE HYDROCHLORIDENALMEFENE HYDROCHLORIDEKnoa Pharma LLC3abfbffc-9e52-4fc6-ae92-6e0a97f4afe72026-05-01Warnings, Adverse reactionsExact identifier
unii: K7K69QC05X
OPVEENALMEFENE HYDROCHLORIDEIndivior Inc.999a4269-9e54-4801-b2ac-2a7276f0b94f2026-01-08Warnings, Adverse reactionsExact identifier
application number: NDA217470
ndc (package): 12496-0003-1
ndc (package): 12496-0003-2
ndc (product): 12496-0003
ndc11 (package): 12496000301
rxcui: 2639727
rxcui: 2639721
spl id: 47e34536-62c2-9ceb-e063-6294a90a57be
spl set id: 999a4269-9e54-4801-b2ac-2a7276f0b94f
unii: K7K69QC05X
nalmefene hydrochlorideNALMEFENE HYDROCHLORIDE INJECTIONChengdu Shuode Pharmaceutical Co., Ltd22d67228-6c24-47ca-afc7-52ef279520a02023-12-08Warnings, Adverse reactionsExact identifier
unii: K7K69QC05X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.