Home NDC 83245-003 REZENOPY
Product NDC 83245-003
11-digit product format 832450003
Labeler code 83245
Product ID 83245-003_6585ecb7-d8c3-4f64-b485-8d0f0c61d376
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name naloxone HCl
Dosage form SPRAY
Route NASAL
Labeler Scienture LLC
Application NDA215487
Marketing category NDA
Marketing start 2026-01-29
Substance NALOXONE HYDROCHLORIDE
Active strength 10 mg/.11mL
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 43 .
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 N215487-001 REZENOPY NALOXONE HYDROCHLORIDE 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19
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 N215487-001 12514854 2041-02-05 U-4397 2026-01-29 N215487-001 12622903 2041-02-05 Drug product 2026-06-03
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215487-001 NP 2027-04-19
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 2026-09-14 22:38:34 2026-08 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD 2024-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD 2024-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215487-001 REZENOPY 10MG/SPRAY SPRAY / NASAL RLD, RS 2024-04-19 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 2026-09-14 22:38:34 2026-08 N215487-001 12514854 2041-02-05 U-4397 2026-01-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N215487-001 12622903 2041-02-05 Drug product 2026-06-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215487-001 12514854 2041-02-05 U-4397 2026-01-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215487-001 12622903 2041-02-05 Drug product 2026-06-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215487-001 12514854 2041-02-05 U-4397 2026-01-29 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215487-001 12514854 2041-02-05 U-4397 2026-01-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215487-001 12622903 2041-02-05 Drug product 2026-06-03 a50c72e98297…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base REZENOPY
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NALOXONE HYDROCHLORIDE 10 mg/.11mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F850569PQR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2704891 Internal RxNorm lookup 2704898 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 83245-003-01 REZENOPY 2 in 1 CARTON SPRAY 2 7 83245-003-01 REZENOPY 1 in 1 BLISTER PACK SPRAY 1 7
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 83245-003-01 83245000301 2 BLISTER PACK in 1 CARTON (83245-003-01) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .11 mL in 1 VIAL, SINGLE-DOSE 2 blister pack 2026-01-29 No No Current