Home NDC 59467-679 KLOXXADO
Product NDC 59467-679
11-digit product format 594670679
Labeler code 59467
Product ID 59467-679_da424329-9a63-4df3-bced-4157d2086e20
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naloxone HCL
Dosage form SPRAY
Route NASAL
Labeler Hikma Specialty USA Inc.
Application NDA212045
Marketing category NDA
Marketing start 2021-08-03
Substance NALOXONE HYDROCHLORIDE
Active strength 8 mg/.1mL
Pharmacologic classes Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212045-001 KLOXXADO NALOXONE HYDROCHLORIDE 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 N212045-002 KLOXXADO NALOXONE HYDROCHLORIDE 4MG/SPRAY SPRAY / NASAL RLD 2025-08-25
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212045-001 10722510 2034-08-26 U-3110 Drug product 2021-05-19 N212045-001 10973814 2034-08-26 U-3110 Drug product 2021-05-19 N212045-001 11135155 2034-08-26 Drug product 2022-03-29 N212045-001 11617713 2034-08-26 U-3110 Drug product 2023-04-28 N212045-001 11628139 2034-08-26 U-3110 Drug product 2023-04-28 N212045-001 11975096 2034-08-26 Drug product 2024-12-04 N212045-001 12414915 2034-08-26 Drug product 2025-09-30
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 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212045-002 KLOXXADO 4MG/SPRAY SPRAY / NASAL RLD 2025-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212045-002 KLOXXADO 4MG/SPRAY SPRAY / NASAL RLD 2025-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212045-001 KLOXXADO 8MG/SPRAY SPRAY / NASAL RLD, RS 2021-04-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212045-002 KLOXXADO 4MG/SPRAY SPRAY / NASAL RLD 2025-08-25 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 151 observed states.
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 N212045-001 10722510 2034-08-26 U-3110 Drug product 2021-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212045-001 10973814 2034-08-26 U-3110 Drug product 2021-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212045-001 11135155 2034-08-26 Drug product 2022-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212045-001 11617713 2034-08-26 U-3110 Drug product 2023-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212045-001 11628139 2034-08-26 U-3110 Drug product 2023-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212045-001 11975096 2034-08-26 Drug product 2024-12-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212045-001 12414915 2034-08-26 Drug product 2025-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212045-001 10722510 2034-08-26 U-3110 Drug product 2021-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212045-001 10973814 2034-08-26 U-3110 Drug product 2021-05-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212045-001 11135155 2034-08-26 Drug product 2022-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212045-001 11617713 2034-08-26 U-3110 Drug product 2023-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212045-001 11628139 2034-08-26 U-3110 Drug product 2023-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212045-001 11975096 2034-08-26 Drug product 2024-12-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212045-001 12414915 2034-08-26 Drug product 2025-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212045-001 10722510 2034-08-26 U-3110 Drug product 2021-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212045-001 10973814 2034-08-26 U-3110 Drug product 2021-05-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212045-001 11135155 2034-08-26 Drug product 2022-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212045-001 11617713 2034-08-26 U-3110 Drug product 2023-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212045-001 11628139 2034-08-26 U-3110 Drug product 2023-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212045-001 11975096 2034-08-26 Drug product 2024-12-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212045-001 10722510 2034-08-26 U-3110 Drug product 2021-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212045-001 10973814 2034-08-26 U-3110 Drug product 2021-05-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212045-001 11135155 2034-08-26 Drug product 2022-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212045-001 11617713 2034-08-26 U-3110 Drug product 2023-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212045-001 11628139 2034-08-26 U-3110 Drug product 2023-04-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212045-001 11975096 2034-08-26 Drug product 2024-12-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212045-001 10722510 2034-08-26 U-3110 Drug product 2021-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212045-001 10973814 2034-08-26 U-3110 Drug product 2021-05-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212045-001 11135155 2034-08-26 Drug product 2022-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212045-001 11617713 2034-08-26 U-3110 Drug product 2023-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212045-001 11628139 2034-08-26 U-3110 Drug product 2023-04-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212045-001 11975096 2034-08-26 Drug product 2024-12-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212045-001 10722510 2034-08-26 U-3110 Drug product 2021-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212045-001 10973814 2034-08-26 U-3110 Drug product 2021-05-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212045-001 11135155 2034-08-26 Drug product 2022-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212045-001 11617713 2034-08-26 U-3110 Drug product 2023-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212045-001 11628139 2034-08-26 U-3110 Drug product 2023-04-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212045-001 11975096 2034-08-26 Drug product 2024-12-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212045-001 10722510 2034-08-26 U-3110 Drug product 2021-05-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212045-001 10973814 2034-08-26 U-3110 Drug product 2021-05-19 2680178bc6a6…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212045-001 NP 2024-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212045-001 NP 2024-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212045-001 NP 2024-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212045-001 NP 2024-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212045-001 NP 2024-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212045-001 NP 2024-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212045-001 NP 2024-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212045-001 NP 2024-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212045-001 NP 2024-04-29 8072bd15b7f6…
Additional Listing Data#
Finished product Yes
Brand name base KLOXXADO
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NALOXONE HYDROCHLORIDE 8 mg/.1mL
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 2540703 Internal RxNorm lookup 2540709 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 59467-679-01 KLOXXADO 0.1 mL in 1 VIAL, SINGLE-DOSE SPRAY 0.1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59467-679 KLOXXADO (NALOXONE HCL) SPRAY [HIKMA SPECIALTY USA INC.] 4 Current NDC, Legacy NDC, 1 package rows 20240531_ebf0f833-c1c0-487c-8f29-01fa8c61b6cb.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 Marketing start Marketing end Sample Exclude flag Status 59467-679-01 59467067901 .1 mL in 1 VIAL, SINGLE-DOSE (59467-679-01) 2021-08-03 0000-00-00 No No Current