Goprelto

Product NDC: 70839-359
11-digit product format: 708390359
Labeler code: 70839
Product ID: 70839-359_0f897764-fe31-090a-e063-6294a90af106
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: cocaine hydrochloride
Dosage form: SOLUTION
Route: NASAL
Labeler: LXO US Inc.
Application: NDA209963
Marketing category: NDA
Marketing start: 2024-02-09
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.

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Goprelto
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1995288	Internal RxNorm lookup
1995293	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0f897764-fe30-090a-e063-6294a90af106	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
dc803e48-5aa8-4a87-8ab4-fcff7feb5dd5	Product name	1	20200610
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
8e5656e6-cd09-45b0-8d65-fbeaa5f1dc4e	Product name	1	20180220
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70839-359-04	Goprelto	1 in 1 CARTON	SOLUTION	1		1
70839-359-04	Goprelto	4 mL in 1 BOTTLE, GLASS	SOLUTION	4		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70839-359	GOPRELTO (COCAINE HYDROCHLORIDE) SOLUTION [LXO US INC.]	1	Current NDC, 2 package rows	20241107_0f897764-fe30-090a-e063-6294a90af106.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 ndc (product): 70839-359
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1995288	cocaine hydrochloride 4 % Nasal Solution	PSN	0f897764-fe30-090a-e063-6294a90af106	1
1995293	GOPRELTO 4 % Nasal Solution	PSN	0f897764-fe30-090a-e063-6294a90af106	1
1995293	cocaine hydrochloride 40 MG/ML Nasal Solution [Goprelto]	SBD	0f897764-fe30-090a-e063-6294a90af106	1
1995288	cocaine hydrochloride 40 MG/ML Nasal Solution	SCD	0f897764-fe30-090a-e063-6294a90af106	1
1995288	cocaine hydrochloride 4 % Nasal Solution	SY	0f897764-fe30-090a-e063-6294a90af106	1
1995293	Goprelto 4 % Nasal Solution	SY	0f897764-fe30-090a-e063-6294a90af106	1
1995293	Goprelto 40 MG/ML Nasal Solution	SY	0f897764-fe30-090a-e063-6294a90af106	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70839-359-04	70839035904	1 BOTTLE, GLASS in 1 CARTON (70839-359-04) / 4 mL in 1 BOTTLE, GLASS	2024-02-09	No	No	Current