Home NDC 76329-3669-2 REXTOVY
Product NDC 76329-3669
Requested package NDC 76329-3669-2
11-digit product format 763293669
Labeler code 76329
Product ID 76329-3669_3bfbdfba-2f14-4e34-9abc-6555d4a3d093
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naloxone Hydrochloride
Dosage form SPRAY
Route NASAL
Labeler International Medication Systems, Ltd.
Application NDA208969
Marketing category NDA
Marketing start 2024-05-07
Marketing end 2027-03-31
Substance NALOXONE HYDROCHLORIDE
Active strength 4 mg/.25mL
Pharmacologic classes Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 N208969-001 REXTOVY NALOXONE HYDROCHLORIDE 4MG/SPRAY SPRAY, METERED / NASAL RLD 2023-03-07
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208969-001 NP 2026-03-07
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 2026-11-14 07:37:17 2026-10 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD 2023-03-07 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 c2088c7a36db…2026-09-14 22:38:34 2026-08 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD 2023-03-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD 2023-03-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD 2023-03-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD 2023-03-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208969-001 NALOXONE HYDROCHLORIDE 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208969-001 NALOXONE HYDROCHLORIDE 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N208969-001 REXTOVY 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 2023-03-07 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 REXTOVY Active Ingredients# Ingredient, Strength table Ingredient Strength NALOXONE HYDROCHLORIDE 4 mg/.25mL
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 2637879 Internal RxNorm lookup 2680741 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 76329-3669-2 REXTOVY 2 in 1 CONTAINER SPRAY 2 8 76329-3669-2 REXTOVY 0.25 mL in 1 CONTAINER SPRAY 0.25 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76329-3669 REXTOVY (NALOXONE HYDROCHLORIDE) SPRAY [INTERNATIONAL MEDICATION SYSTEMS, LTD.] 8 Current NDC, 2 package rows 20240530_fe9735db-c57e-44a8-bffb-b87a84c2a6f3.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76329-3669-2 76329366902 2 CONTAINER in 1 CONTAINER (76329-3669-2) / .25 mL in 1 CONTAINER 2 container 2024-05-07 2027-03-31 No No Historical