Home NDC 64950-359 GOPRELTO
Product NDC 64950-359
11-digit product format 649500359
Labeler code 64950
Product ID 64950-359_9ce80d99-cd39-4a9e-b2a6-207b4ed1f68d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cocaine hydrochloride
Dosage form SOLUTION
Route NASAL
Labeler Genus Lifesciences Inc.
Application NDA209963
Marketing category NDA
Marketing start 2018-01-08
Marketing end 0000-00-00
Substance COCAINE HYDROCHLORIDE
Active strength 40 mg/mL
DEA schedule CII
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64950-359-04 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64950-359-04 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64950-359-04 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64950-359-04 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64950-359-04 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64950-359-04 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64950-359-04 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64950-359-04 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64950-359-04 0efc9e666f02…f202fb6c5f17…
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# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 64950-359-04 64950035904 1 BOTTLE, GLASS in 1 CARTON (64950-359-04) > 4 mL in 1 BOTTLE, GLASS 2018-01-08 0000-00-00 No No Current