Home NDC 76329-3669 REXTOVY
Product NDC 76329-3669
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 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 N208969-001 REXTOVY NALOXONE HYDROCHLORIDE 4MG/SPRAY SPRAY, METERED / NASAL RLD, RS 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 2026-09-14 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
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
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join REXTOVY NALOXONE HYDROCHLORIDE International Medication Systems, Ltd. fe9735db-c57e-44a8-bffb-b87a84c2a6f3 2024-05-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 208969 application number: NDA208969 ndc (product): 76329-3669
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