cocaine hydrochloride

Product NDC: 64950-362
11-digit product format: 649500362
Labeler code: 64950
Product ID: 64950-362_ae2018a6-697a-47be-bfa1-c94d23f1353d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cocaine hydrochloride
Dosage form: SOLUTION
Route: NASAL
Labeler: Genus Lifesciences Inc.
Application: NDA209963
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2018-06-04
Marketing end: 0000-00-00
Substance: COCAINE HYDROCHLORIDE
Active strength: 40 mg/mL
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	64950-362		D	Discontinued by firm		2026-08-17
excluded package	package	64950-362	64950-362-04	D	Discontinued by firm		2026-08-17

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64950-362	64950-362-04	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64950-362	64950-362-04	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209963-001	10016407	2037-02-07	U-2329		2018-07-20
N209963-001	10149843	2037-02-07	U-2478		2019-01-10
N209963-001	10149843	2037-02-07	U-2479		2019-01-10
N209963-001	10231961	2037-02-07		Drug product	2019-04-15
N209963-001	10413505	2037-02-07	U-2479		2019-10-16
N209963-001	10420760	2037-02-07	U-2478		2019-10-23
N209963-001	10857095	2037-02-07	U-3014		2021-01-06
N209963-001	10894012	2037-02-07	U-3014		2021-02-11
N209963-001	10933060	2037-02-07	U-3014		2021-04-01
N209963-001	10973811	2037-02-07	U-2226		2021-05-13
N209963-001	10987347	2037-02-07	U-2225		2021-05-27
N209963-001	11040032	2037-02-07		Drug product	2021-12-09
N209963-001	9867815	2037-02-07	U-2225		2018-01-31
N209963-001	9867815	2037-02-07	U-2226		2018-01-31
N209963-001	9867815	2037-02-07	U-2227		2018-01-31

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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209963-001	NCE	2022-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209963-001	NCE	2022-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209963-001	NCE	2022-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209963-001	NCE	2022-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209963-001	NCE	2022-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209963-001	NCE	2022-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209963-001	NCE	2022-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209963-001	NCE	2022-12-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209963-001	NCE	2022-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209963-001	NCE	2022-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209963-001	NCE	2022-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209963-001	NCE	2022-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209963-001	NCE	2022-12-14	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N209963-001	NCE	2022-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209963-001	NCE	2022-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209963-001	NCE	2022-12-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209963-001	NCE	2022-12-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209963-001	NCE	2022-12-14	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64950-362-04	ML - Milliliter	64950-362	31289558-574d-442d-99f3-7408e3fe208b	1	2018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64950-362	COCAINE HYDROCHLORIDE SOLUTION [GENUS LIFESCIENCES INC.]	6	Legacy NDC	20240305_b555c752-eae8-4d17-bb35-813ba9805448.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Goprelto	COCAINE HYDROCHLORIDE	LXO US Inc.	0f897764-fe30-090a-e063-6294a90af106	2024-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209963 application number: NDA209963
COCAINE HYDROCHLORIDE	COCAINE HYDROCHLORIDE	LXO US INC.	0fb0298f-9756-26e8-e063-6294a90ae8f2	2024-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209963 application number: NDA209963

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
XH8T8T6WZH	COCAINE HYDROCHLORIDE	53-21-4	COCAINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64950-362-04	64950036204	1 BOTTLE, GLASS in 1 CARTON (64950-362-04) > 4 mL in 1 BOTTLE, GLASS	2018-06-04	0000-00-00	No	No	Current