Spravato

Product NDC: 50458-028
11-digit product format: 504580028
Labeler code: 50458
Product ID: 50458-028_edb747c7-957a-47fa-b5b2-51a25b31c083
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Esketamine Hydrochloride
Dosage form: SOLUTION
Route: NASAL
Labeler: Janssen Pharmaceuticals Inc.
Application: NDA211243
Marketing category: NDA
Marketing start: 2019-03-05
Substance: ESKETAMINE HYDROCHLORIDE
Active strength: 28 mg/.2mL
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N211243-001	SPRAVATO	ESKETAMINE HYDROCHLORIDE	EQ 28MG BASE	SPRAY / NASAL		RLD, RS	2019-03-05

Orange Book patents#

Current patent rows page 1 of 1 · 25 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N211243-001	9592207	2027-03-20	U-2502	2019-04-03
N211243-001	9592207	2027-03-20	U-4112	2019-04-03
N211243-001	8785500	2033-03-05	U-2502	2019-04-03
N211243-001	8785500	2033-03-05	U-4112	2019-04-03
N211243-001	11446260	2034-03-14	U-3444	2022-10-14
N211243-001	11446260	2034-03-14	U-3445	2022-10-14
N211243-001	11446260	2034-03-14	U-3446	2022-10-14
N211243-001	11446260	2034-03-14	U-4118	2022-10-14
N211243-001	11446260	2034-03-14	U-4119	2022-10-14
N211243-001	10869844	2035-09-10	U-3034	2021-01-15
N211243-001	10869844	2035-09-10	U-3035	2021-01-15
N211243-001	10869844	2035-09-10	U-3036	2021-01-15
N211243-001	10869844	2035-09-10	U-4113	2021-01-15
N211243-001	10869844	2035-09-10	U-4114	2021-01-15
N211243-001	11173134	2035-09-10	U-3257	2021-12-16
N211243-001	11173134	2035-09-10	U-3536	2021-12-16
N211243-001	11173134	2035-09-10	U-4115	2021-12-16
N211243-001	11311500	2035-09-10	U-3034	2022-05-26
N211243-001	11311500	2035-09-10	U-3035	2022-05-26
N211243-001	11311500	2035-09-10	U-3036	2022-05-26
N211243-001	11311500	2035-09-10	U-4116	2022-05-26
N211243-001	11311500	2035-09-10	U-4117	2022-05-26
N211243-001	11883526	2040-02-18	U-3812	2024-02-16
N211243-001	11883526	2040-02-18	U-3813	2024-02-16
N211243-001	11883526	2040-02-18	U-4120	2024-02-16

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211243-001	I-959	2028-01-17

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 546 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N211243-001	9592207	2027-03-20	U-2502	2019-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	9592207	2027-03-20	U-4112	2019-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	8785500	2033-03-05	U-2502	2019-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	8785500	2033-03-05	U-4112	2019-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11446260	2034-03-14	U-4118	2022-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11446260	2034-03-14	U-4119	2022-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11446260	2034-03-14	U-3444	2022-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11446260	2034-03-14	U-3445	2022-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11446260	2034-03-14	U-3446	2022-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	10869844	2035-09-10	U-4113	2021-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	10869844	2035-09-10	U-4114	2021-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	10869844	2035-09-10	U-3035	2021-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	10869844	2035-09-10	U-3034	2021-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	10869844	2035-09-10	U-3036	2021-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11173134	2035-09-10	U-4115	2021-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11173134	2035-09-10	U-3536	2021-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11173134	2035-09-10	U-3257	2021-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11311500	2035-09-10	U-4116	2022-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11311500	2035-09-10	U-4117	2022-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11311500	2035-09-10	U-3034	2022-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11311500	2035-09-10	U-3036	2022-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11311500	2035-09-10	U-3035	2022-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11883526	2040-02-18	U-4120	2024-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11883526	2040-02-18	U-3812	2024-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11883526	2040-02-18	U-3813	2024-02-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211243-001	9592207	2027-03-20	U-2502	2019-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	9592207	2027-03-20	U-4112	2019-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	8785500	2033-03-05	U-2502	2019-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	8785500	2033-03-05	U-4112	2019-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	11446260	2034-03-14	U-4118	2022-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	11446260	2034-03-14	U-4119	2022-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	11446260	2034-03-14	U-3444	2022-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	11446260	2034-03-14	U-3445	2022-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	11446260	2034-03-14	U-3446	2022-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	10869844	2035-09-10	U-4113	2021-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	10869844	2035-09-10	U-4114	2021-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	10869844	2035-09-10	U-3035	2021-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	10869844	2035-09-10	U-3034	2021-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	10869844	2035-09-10	U-3036	2021-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	11173134	2035-09-10	U-4115	2021-12-16	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N211243-001	I-959	2028-01-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211243-001	I-959	2028-01-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211243-001	I-959	2028-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211243-001	I-959	2028-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211243-001	I-959	2028-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211243-001	I-959	2028-01-17	`fd3edfee7708…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211243-001	NCE*	2024-03-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211243-001	NCE*	2024-03-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211243-001	NCE*	2024-03-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211243-001	NCE*	2024-03-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211243-001	NCE*	2024-03-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211243-001	NCE*	2024-03-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211243-001	NCE*	2024-03-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211243-001	NCE*	2024-03-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211243-001	NCE*	2024-03-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211243-001	I-840	2023-07-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211243-001	NCE*	2024-03-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211243-001	I-840	2023-07-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211243-001	NCE*	2024-03-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211243-001	I-840	2023-07-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211243-001	NCE*	2024-03-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211243-001	NCE*	2024-03-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211243-001	I-840	2023-07-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N211243-001	NCE*	2024-03-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211243-001	I-840	2023-07-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N211243-001	NCE*	2024-03-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211243-001	I-840	2023-07-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211243-001	NCE*	2024-03-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211243-001	I-840	2023-07-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N211243-001	NCE*	2024-03-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211243-001	I-840	2023-07-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N211243-001	NCE*	2024-03-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211243-001	I-840	2023-07-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N211243-001	NCE*	2024-03-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211243-001	NCE*	2024-03-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211243-001	NCE*	2024-03-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N211243-001	NCE*	2024-03-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211243-001	NCE*	2024-03-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211243-001	NCE*	2024-03-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211243-001	I-840	2023-07-31	`ea1830bbd6c7…`

Additional Listing Data#

Finished product: Yes
Brand name base: Spravato
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESKETAMINE HYDROCHLORIDE	28 mg/.2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L8P1H35P2Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2119381	Internal RxNorm lookup
2119387	Internal RxNorm lookup
2119388	Internal RxNorm lookup
2119389	Internal RxNorm lookup
2119390	Internal RxNorm lookup
2119391	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
d81a6a79-a74a-44b7-822c-0dfa3036eaed	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
78f6246b-a57c-4cd9-98c2-73b0767a033f	Product name	1	20190618

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50458-028-00	Spravato	0.2 mL in 1 VIAL, SINGLE-USE	SOLUTION	0.2	18
50458-028-02	Spravato	1 in 1 BLISTER PACK	SOLUTION	1	18
50458-028-02	Spravato	2 in 1 KIT	SOLUTION	2	18
50458-028-03	Spravato	3 in 1 KIT	SOLUTION	3	18
50458-028-03	Spravato	1 in 1 BLISTER PACK	SOLUTION	1	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50458-028-00	EA - Each	50458-028	bebd456d-478d-4351-948f-e287dd1e023b	1	2019-04-11
50458-028-02	EA - Each	50458-028	c31f11b0-2ebd-4f8d-b134-b1b7b91c3b3b	1	2019-04-11
50458-028-03	EA - Each	50458-028	68e59244-29fd-4679-8d6b-b43daaf897d8	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50458-028	SPRAVATO (ESKETAMINE HYDROCHLORIDE) SOLUTION [JANSSEN PHARMACEUTICALS INC.]	16	Current NDC, Legacy NDC, 5 package rows	20250514_d81a6a79-a74a-44b7-822c-0dfa3036eaed.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Spravato	ESKETAMINE HYDROCHLORIDE	Janssen Pharmaceuticals, Inc.	d81a6a79-a74a-44b7-822c-0dfa3036eaed	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 211243 application number: NDA211243 ndc (product): 50458-028

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L8P1H35P2Z	ESKETAMINE HYDROCHLORIDE	33643-47-9	ESKETAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2119391	{2 (0.2 ML) (esketamine 140 MG/ML Nasal Spray [Spravato]) } Pack [Spravato 56 MG Dose Kit]	BPCK	d81a6a79-a74a-44b7-822c-0dfa3036eaed	18
2119389	{3 (0.2 ML) (esketamine 140 MG/ML Nasal Spray [Spravato]) } Pack [Spravato 84 MG Dose Kit]	BPCK	d81a6a79-a74a-44b7-822c-0dfa3036eaed	18
2119390	{2 (0.2 ML) (esketamine 140 MG/ML Nasal Spray) } Pack	GPCK	d81a6a79-a74a-44b7-822c-0dfa3036eaed	18
2119388	{3 (0.2 ML) (esketamine 140 MG/ML Nasal Spray) } Pack	GPCK	d81a6a79-a74a-44b7-822c-0dfa3036eaed	18
2119381	esketamine 140 MG/mL Nasal Spray	PSN	d81a6a79-a74a-44b7-822c-0dfa3036eaed	18
2119390	esketamine HCl 56 MG (28 MG x 2) Nasal Spray	PSN	d81a6a79-a74a-44b7-822c-0dfa3036eaed	18
2119388	esketamine HCl 84 MG (28 MG x 3) Nasal Spray	PSN	d81a6a79-a74a-44b7-822c-0dfa3036eaed	18
2119387	Spravato 28 MG in 0.2 mL Nasal Spray	PSN	d81a6a79-a74a-44b7-822c-0dfa3036eaed	18
2119391	Spravato 56 MG Dose Kit	PSN	d81a6a79-a74a-44b7-822c-0dfa3036eaed	18
2119389	Spravato 84 MG Dose Kit	PSN	d81a6a79-a74a-44b7-822c-0dfa3036eaed	18
2119387	esketamine 140 MG/ML Nasal Spray [Spravato]	SBD	d81a6a79-a74a-44b7-822c-0dfa3036eaed	18
2119381	esketamine 140 MG/ML Nasal Spray	SCD	d81a6a79-a74a-44b7-822c-0dfa3036eaed	18
2119390	esketamine 140 MG/mL Metered Dose Nasal Spray (2- 0.2 OZ Pack)	SY	d81a6a79-a74a-44b7-822c-0dfa3036eaed	18
2119388	esketamine 140 MG/mL Nasal Spray (3- 0.2 OZ Pack)	SY	d81a6a79-a74a-44b7-822c-0dfa3036eaed	18
2119387	Spravato 140 MG/ML Nasal Spray	SY	d81a6a79-a74a-44b7-822c-0dfa3036eaed	18
2119387	Spravato 28 MG per 0.2 ML Nasal Spray	SY	d81a6a79-a74a-44b7-822c-0dfa3036eaed	18
2119391	Spravato 56 MG Dose Kit	SY	d81a6a79-a74a-44b7-822c-0dfa3036eaed	18
2119389	Spravato 84 MG Dose Kit	SY	d81a6a79-a74a-44b7-822c-0dfa3036eaed	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50458-028-00	50458002800	0.2 mL in 1 VIAL, SINGLE-USE	0.2 ml					Historical
50458-028-02	50458002802	2 BLISTER PACK in 1 KIT (50458-028-02) / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00)	2 blister pack	2019-03-05	0000-00-00	No	No	Current
50458-028-03	50458002803	3 BLISTER PACK in 1 KIT (50458-028-03) / 1 VIAL, SINGLE-USE in 1 BLISTER PACK / .2 mL in 1 VIAL, SINGLE-USE (50458-028-00)	3 blister pack	2019-03-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Spravato	Janssen Pharmaceuticals Inc. \| Renaissance Lakewood LLC \| Janssen Pharmaceuticals, Inc. \| CU Chemie Uetikon GmbH \| Janssen Pharmaceutica NV \| Janssen Ortho LLC \| PPD Development, LP. \| Janssen Pharmaceuticals, Inc \| Janssen-Cilag Manufacturing, LLC	2026-07-29	HUMAN PRESCRIPTION DRUG LABEL	19