Home NDC 12496-0003 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217470-001 OPVEE NALMEFENE HYDROCHLORIDE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 N217470-001 12290596 2042-08-04 U-4182 2025-05-20
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N217470-001 NP 2026-05-22
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217470-001 OPVEE EQ 2.7MG BASE/SPRAY SPRAY / NASAL RLD, RS 2023-05-22 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217470-001 12290596 2042-08-04 U-4182 2025-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217470-001 12290596 2042-08-04 U-4182 2025-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217470-001 12290596 2042-08-04 U-4182 2025-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 a67488948f0b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217470-001 11458091 2038-07-10 U-3630 Drug product 2023-06-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217470-001 12290596 2042-08-04 U-4182 2025-05-20 a50c72e98297…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base OPVEE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NALMEFENE HYDROCHLORIDE 2.7 mg/100uL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K7K69QC05X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2639721 Internal RxNorm lookup 2639727 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 12496-0003-1 OPVEE 100 uL in 1 VIAL, SINGLE-DOSE SPRAY 100 8 12496-0003-1 OPVEE 1 in 1 BLISTER PACK SPRAY 1 8 12496-0003-2 OPVEE 2 in 1 CARTON SPRAY 2 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12496-0003 OPVEE (NALMEFENE HYDROCHLORIDE) SPRAY [INDIVIOR INC.] 6 Current NDC, 3 package rows 20241114_999a4269-9e54-4801-b2ac-2a7276f0b94f.zip
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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 12496-0003-1 12496000301 100 uL in 1 VIAL, SINGLE-DOSE 100 ul Historical 12496-0003-2 12496000302 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 2 blister pack 2023-10-02 No No Current