Home NDC 70839-362 COCAINE HYDROCHLORIDE
Product NDC 70839-362
11-digit product format 708390362
Labeler code 70839
Product ID 70839-362_0fb0298f-9757-26e8-e063-6294a90ae8f2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name COCAINE HYDROCHLORIDE
Dosage form SOLUTION
Route NASAL
Labeler LXO US INC.
Application NDA209963
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2024-01-29
Substance COCAINE HYDROCHLORIDE
Active strength 40 mg/mL
DEA schedule CII
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 42 .
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 N209963-001 GOPRELTO COCAINE HYDROCHLORIDE 4% SOLUTION / NASAL RLD, RS 2017-12-14
Orange Book patents# Current patent rows page 1 of 1 · 15 matching rows.
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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209963-001 GOPRELTO 4% SOLUTION / NASAL RLD, RS 2017-12-14 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 15 · 581 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N209963-001 10016407 2037-02-07 U-2329 2018-07-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209963-001 10149843 2037-02-07 U-2479 2019-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209963-001 10149843 2037-02-07 U-2478 2019-01-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209963-001 10231961 2037-02-07 Drug product 2019-04-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209963-001 10413505 2037-02-07 U-2479 2019-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209963-001 10420760 2037-02-07 U-2478 2019-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209963-001 10857095 2037-02-07 U-3014 2021-01-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209963-001 10894012 2037-02-07 U-3014 2021-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209963-001 10933060 2037-02-07 U-3014 2021-04-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209963-001 10973811 2037-02-07 U-2226 2021-05-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209963-001 10987347 2037-02-07 U-2225 2021-05-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209963-001 11040032 2037-02-07 Drug product 2021-12-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209963-001 9867815 2037-02-07 U-2225 2018-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209963-001 9867815 2037-02-07 U-2226 2018-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209963-001 9867815 2037-02-07 U-2227 2018-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209963-001 10016407 2037-02-07 U-2329 2018-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209963-001 10149843 2037-02-07 U-2479 2019-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209963-001 10149843 2037-02-07 U-2478 2019-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209963-001 10231961 2037-02-07 Drug product 2019-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209963-001 10413505 2037-02-07 U-2479 2019-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209963-001 10420760 2037-02-07 U-2478 2019-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209963-001 10857095 2037-02-07 U-3014 2021-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209963-001 10894012 2037-02-07 U-3014 2021-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209963-001 10933060 2037-02-07 U-3014 2021-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209963-001 10973811 2037-02-07 U-2226 2021-05-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209963-001 10987347 2037-02-07 U-2225 2021-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209963-001 11040032 2037-02-07 Drug product 2021-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209963-001 9867815 2037-02-07 U-2225 2018-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209963-001 9867815 2037-02-07 U-2226 2018-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209963-001 9867815 2037-02-07 U-2227 2018-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209963-001 10016407 2037-02-07 U-2329 2018-07-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209963-001 10149843 2037-02-07 U-2479 2019-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209963-001 10149843 2037-02-07 U-2478 2019-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209963-001 10231961 2037-02-07 Drug product 2019-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209963-001 10413505 2037-02-07 U-2479 2019-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209963-001 10420760 2037-02-07 U-2478 2019-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209963-001 10857095 2037-02-07 U-3014 2021-01-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209963-001 10894012 2037-02-07 U-3014 2021-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209963-001 10933060 2037-02-07 U-3014 2021-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209963-001 10973811 2037-02-07 U-2226 2021-05-13 31067a03dcf5…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base COCAINE HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COCAINE HYDROCHLORIDE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination XH8T8T6WZH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1995288 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 70839-362-04 COCAINE HYDROCHLORIDE 4 mL in 1 BOTTLE, GLASS SOLUTION 4 1 70839-362-04 COCAINE HYDROCHLORIDE 1 in 1 CARTON SOLUTION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70839-362 COCAINE HYDROCHLORIDE SOLUTION [LXO US INC.] 1 Current NDC, 2 package rows 20240129_0fb0298f-9756-26e8-e063-6294a90ae8f2.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 70839-362-04 70839036204 1 BOTTLE, GLASS in 1 CARTON (70839-362-04) / 4 mL in 1 BOTTLE, GLASS 2024-01-29 No No Current