FDA.reportPublic FDA data

OPVEE

Product NDC
12496-0003
11-digit product format
124960003
Labeler code
12496
Product ID
12496-0003_47e34536-62c2-9ceb-e063-6294a90a57be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nalmefene hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Indivior Inc.
Application
NDA217470
Marketing category
NDA
Marketing start
2023-10-02
Substance
NALMEFENE HYDROCHLORIDE
Active strength
2.7 mg/100uL
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OPVEE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NALMEFENE HYDROCHLORIDE2.7 mg/100uL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK7K69QC05X
Rxcui2639721, 2639727

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e7798c38-a53e-489a-b98c-9f4b01c0aab9Product name220250731
437f042c-2a66-4faa-b06c-0be5226687faProduct name120250313
c8c002c1-b6e1-4b46-8d55-5530f0dfb1b4Product name120231013

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2639721nalmefene 2.7 MG in 0.1 ML Nasal SprayPSN999a4269-9e54-4801-b2ac-2a7276f0b94f8
2639727OPVEE 2.7 MG in 0.1 ML Nasal SprayPSN999a4269-9e54-4801-b2ac-2a7276f0b94f8
2639727nalmefene 27 MG/ML Nasal Spray [Opvee]SBD999a4269-9e54-4801-b2ac-2a7276f0b94f8
2639721nalmefene 27 MG/ML Nasal SpraySCD999a4269-9e54-4801-b2ac-2a7276f0b94f8
2639721nalmefene 2.7 MG (equivalent to nalmefene HCl 3 MG) per 0.1 ML Nasal SpraySY999a4269-9e54-4801-b2ac-2a7276f0b94f8
2639721nalmefene 2.7 MG per 0.1 ML Nasal SpraySY999a4269-9e54-4801-b2ac-2a7276f0b94f8
2639727Opvee 2.7 MG per 0.1 ML Nasal SpraySY999a4269-9e54-4801-b2ac-2a7276f0b94f8
2639727Opvee 27 MG/ML Nasal SpraySY999a4269-9e54-4801-b2ac-2a7276f0b94f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
12496-0003-112496000301100 uL in 1 VIAL, SINGLE-DOSE100 ulHistorical
12496-0003-2124960003022 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-DOSE2 blister pack2023-10-02NoNoCurrent