Spravato

Product NDC: 50458-028
11-digit product format: 504580028
Labeler code: 50458
Product ID: 50458-028_9731f316-79b8-41c8-a056-c1f1dc65f0ef
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

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

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. \| LTS Lakewood LLC \| CU Chemie Uetikon GmbH \| Janssen Pharmaceutica NV \| Janssen Ortho LLC \| PPD Development, LP. \| Janssen Pharmaceuticals Inc. \| Janssen-Cilag Manufacturing, LLC	2026-09-22	HUMAN PRESCRIPTION DRUG LABEL	21